The following data is part of a premarket notification filed by Remel Co. with the FDA for Mueller Hinton Agar W/4% Nacl W/antibiotics.
| Device ID | K850291 |
| 510k Number | K850291 |
| Device Name: | MUELLER HINTON AGAR W/4% NACL W/ANTIBIOTICS |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | James G Baxendale |
| Correspondent | James G Baxendale REMEL CO. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-01-24 |
| Decision Date | 1985-05-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838004520 | K850291 | 000 |
| 00848838004513 | K850291 | 000 |
| 00848838004506 | K850291 | 000 |
| 00848838004490 | K850291 | 000 |
| 00848838002489 | K850291 | 000 |
| 00848838002472 | K850291 | 000 |
| 00848838002465 | K850291 | 000 |
| 00848838002458 | K850291 | 000 |
| 00848838002434 | K850291 | 000 |