The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Bcye Medium.
| Device ID | K812911 |
| 510k Number | K812911 |
| Device Name: | BCYE MEDIUM |
| Classification | Culture Media, Multiple Biochemical Test |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSE |
| CFR Regulation Number | 866.2320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-19 |
| Decision Date | 1981-11-06 |