The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Mueller Hinton Agar.
| Device ID | K811049 |
| 510k Number | K811049 |
| Device Name: | MUELLER HINTON AGAR |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | ACUMEDIA MANUFACTURERS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-04-16 |
| Decision Date | 1981-04-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860003684634 | K811049 | 000 |
| 00860003684627 | K811049 | 000 |
| 00860003684610 | K811049 | 000 |
| 00860003684603 | K811049 | 000 |