The following data is part of a premarket notification filed by Kamiya Biomedical Co. with the FDA for K-assay Cystatin C Reagent, Calibrator And Control.
| Device ID | K093137 |
| 510k Number | K093137 |
| Device Name: | K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL |
| Classification | Test, Cystatin C |
| Applicant | KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. Seattle, WA 98168 |
| Contact | Shawn Kaplan |
| Correspondent | Shawn Kaplan KAMIYA BIOMEDICAL CO. 12779 GATEWAY DR. Seattle, WA 98168 |
| Product Code | NDY |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-05 |
| Decision Date | 2010-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816426020917 | K093137 | 000 |
| 00816426020900 | K093137 | 000 |
| 00816426020771 | K093137 | 000 |
| 00816426020320 | K093137 | 000 |
| 00816426020313 | K093137 | 000 |