The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Antibiotic Assay Broth.
| Device ID | K832575 |
| 510k Number | K832575 |
| Device Name: | ANTIBIOTIC ASSAY BROTH |
| Classification | Culture Media, Antibiotic Assay |
| Applicant | ACUMEDIA MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JSA |
| CFR Regulation Number | 866.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-02 |
| Decision Date | 1983-09-12 |