The following data is part of a premarket notification filed by Gentian As with the FDA for Gentian Cystatin C Immunoassay.
| Device ID | K071388 |
| 510k Number | K071388 |
| Device Name: | GENTIAN CYSTATIN C IMMUNOASSAY |
| Classification | Test, Cystatin C |
| Applicant | GENTIAN AS 9915 CAM. CHIRIMOLLA San Diego, CA 92131 |
| Contact | Ronald G Leonardi |
| Correspondent | Ronald G Leonardi GENTIAN AS 9915 CAM. CHIRIMOLLA San Diego, CA 92131 |
| Product Code | NDY |
| CFR Regulation Number | 862.1225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-18 |
| Decision Date | 2007-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07090038460122 | K071388 | 000 |
| 07090038460115 | K071388 | 000 |
| 07090038460108 | K071388 | 000 |
| 07090038460092 | K071388 | 000 |
| 07090038460085 | K071388 | 000 |
| 07090038460078 | K071388 | 000 |
| 07090038460061 | K071388 | 000 |