ASTORIA-PACIFIC, INC.
Registration 3050015FEI 3050015Clackamas, OR
Owner/operator: ASTORIA-PACIFIC, INC.
- Complaint File Establishment per 21 CFR 820.198
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
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- Dec 1Our pay-by date30 days left
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- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 28
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 28
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| KLI | Accuwell T4 Neonatal Screening EIAEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | Class 2 | 21 CFR 862.1700 | K972974 |
| KQP | SPOTCHECK Uridyltransferase 50 hourFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | Class 2 | 21 CFR 862.1315 | K970277 |
| KQP | SPOTCHECK Neonatal GALT Microplate Rgt KitFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | Class 2 | 21 CFR 862.1315 | K102643 |
| KQP | 307 Digitial Fluorometer/PhotometerFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | Class 2 | 21 CFR 862.1315 | K101392 |
| KQP | SPOTCHECK Total Galactose 50 hr kitFluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase | Class 2 | 21 CFR 862.1315 | K894011 |
| JBL | 307 Digitial Fluorometer/PhotometerGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | Class 2 | 21 CFR 864.7360 | K101392 |
| JBL | SPOTCHECK G6PD 50 hour kitGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative | Class 2 | 21 CFR 864.7360 | K990957 |
| JNB | 307 Digitial Fluorometer/PhotometerNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | Class 2 | 21 CFR 862.1555 | K101392 |
| JNB | SPOTCHECK Phenylalanine 50 hour kitNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | Class 2 | 21 CFR 862.1555 | K891070 |
| JNB | Accuwell Phenylalanine Neonatal Screening KitNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine | Class 2 | 21 CFR 862.1555 | K974047 |
| JLW | Accuwell TSH Neonatal Screening ELISARadioimmunoassay, Thyroid-Stimulating Hormone | Class 2 | 21 CFR 862.1690 | K001455 |
| NAK | SPOTCHECK Biotinidase 50 hour kitSystem, Test, Biotinidase | Class 2 | 21 CFR 862.1118 | K010844 |
and 16 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.