The following data is part of a premarket notification filed by American Biomedical Corp. with the FDA for Mueller Hinton Agar.
| Device ID | K833861 |
| 510k Number | K833861 |
| Device Name: | MUELLER HINTON AGAR |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/broth |
| Applicant | AMERICAN BIOMEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JTZ |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-07 |
| Decision Date | 1983-12-08 |