The following data is part of a premarket notification filed by Gentian As with the FDA for Gentian Cystatin C Immunoassay.
| Device ID | K081875 |
| 510k Number | K081875 |
| Device Name: | GENTIAN CYSTATIN C IMMUNOASSAY |
| Classification | Test, Cystatin C |
| Applicant | GENTIAN AS 9915 CAM. CHIRIMOLLA San Diego, CA 92131 |
| Contact | Eric S Gruff |
| Correspondent | Eric S Gruff GENTIAN AS 9915 CAM. CHIRIMOLLA San Diego, CA 92131 |
| Product Code | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-02 |
| Decision Date | 2008-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17090038460051 | K081875 | 000 |
| 17090038460037 | K081875 | 000 |
| 17090038460020 | K081875 | 000 |
| 17090038460013 | K081875 | 000 |