The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Middlebrook 7h10 Agar Base-lowph.
| Device ID | K823859 |
| 510k Number | K823859 |
| Device Name: | MIDDLEBROOK 7H10 AGAR BASE-LOWPH |
| Classification | Culture Media, Antimycobacteria, Susceptibility Test |
| Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | MJD |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-12-22 |
| Decision Date | 1983-03-08 |