KASHI SCIENTIFIC LLC
Registration 3020831613FEI 3020831613Portland, OR
Owner/operator: Kashi Scientific LLC
- Develop Specifications But Do Not Manufacture At This Facility
- Repack or Relabel 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
- Nov 3Where you stand58 days left
- 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
- 10
- 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 10
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| FMI | Blood Collection Set With Pre-Attached HolderNeedle, Hypodermic, Single Lumen | Class 2 | 21 CFR 880.5570 | K153388 |
| JKA | Gel & Clot Activator TubeTubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | 21 CFR 862.1675 | K093910 |
| KXG | Disposable Cytology BrushApplicator, Absorbent Tipped, Sterile | Class 1 | 21 CFR 880.6025 | — |
| JJH | Blood DNA/RNA Extraction KitClinical Sample Concentrator | Class 1 | 21 CFR 862.2310 | — |
| KDT | Urine Sample ContainerContainer, Specimen Mailer And Storage, Sterile | Class 1 | 21 CFR 864.3250 | — |
| JSG | CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIALCulture Media, Non-Selective And Non-Differential | Class 1 | 21 CFR 866.2300 | — |
| JSF | Universal Viral Transport Medium KitCulture Media, Single Biochemical Test | Class 1 | 21 CFR 866.2320 | — |
| BTP | Universal Pipette TipsDropper, Ether | Class 1 | 21 CFR 868.5420 | — |
| LZA | Powder-Free Nitrile Examination GlovesPolymer Patient Examination Glove | Class 1 | 21 CFR 880.6250 | K003985 |
| KST | Conventional Holder - General TypeSystem, Blood Collection, Vacuum-Assisted, Manual | Class 1 | 21 CFR 864.9125 | — |
What changed
Nothing added in the last twelve months, and no change seen on the record yet.