The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Antibiotic Medium #10 Polymyxin Seed Agar.
| Device ID | K881538 |
| 510k Number | K881538 |
| Device Name: | ANTIBIOTIC MEDIUM #10 POLYMYXIN SEED AGAR |
| Classification | Culture Media, Antibiotic Assay |
| Applicant | ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore, MD 21211 |
| Contact | Cunningham, Phd |
| Correspondent | Cunningham, Phd ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore, MD 21211 |
| Product Code | JSA |
| CFR Regulation Number | 866.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-08 |
| Decision Date | 1988-04-18 |