The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Fildes Enrichment Soluton.
| Device ID | K830383 |
| 510k Number | K830383 |
| Device Name: | FILDES ENRICHMENT SOLUTON |
| Classification | Culture Media, Enriched |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KZI |
| CFR Regulation Number | 866.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-04 |
| Decision Date | 1983-03-08 |