CLINICAL DIAGNOSTIC SOLUTIONS, INC.
Registration 1064130FEI 3002684533PLANTATION, FL
Owner/operator: Boule Diagnostics AB
- Manufacture Medical Device
- Manufacture Medical Device for Another Party (Contract Manufacturer)
- 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.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- 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 |
|---|---|---|---|---|
| KRZ | Calibrator For Hemoglobin And Hematocrit MeasurementHematology | Class 2 | 21 CFR 864.8165 | K041130 |
| KRY | Calibrator For Platelet CountingHematology | Class 2 | 21 CFR 864.8175 | K041130 |
| KSA | Calibrator For Red-Cell And White-Cell CountingHematology | Class 2 | 21 CFR 864.8185 | K041130 |
| OYE | Flow Cytometric Reagents And Accessories.Hematology | Class 2 | 21 CFR 864.5220 | — |
| JPK | Mixture, Hematology Quality ControlHematology | Class 2 | 21 CFR 864.8625 | K024173 |
| JCB | 501-002 ENZYMATIC CLEANERDetergent | Class 1 | 21 CFR 864.4010 | — |
| GIF | 501-003 HEMATOLOGY DILUENTDiluent, Blood Cell | Class 1 | 21 CFR 864.8200 | — |
| KIP | 501-050 CDS SHEATH REAGENTFormulations, Balanced Salt Solutions | Class 1 | 21 CFR 864.2875 | — |
| PPM | 501-009 CDS 5-PD Reagent SetGeneral Purpose Reagent | Class 1 | 21 CFR 864.4010 | — |
| GGK | 501-464 Medonic M-Series LyseProducts, Red-Cell Lysing Products | Class 1 | 21 CFR 864.8540 | — |
What changed
Nothing added in the last twelve months, and no change seen on the record yet.