The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Yeast Beef Agar-antibiotic Med.4.
| Device ID | K833218 |
| 510k Number | K833218 |
| Device Name: | YEAST BEEF AGAR-ANTIBIOTIC MED.4 |
| Classification | Culture Media, Antimicrobial Susceptibility Test |
| Applicant | ACUMEDIA MANUFACTURERS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LKA |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-19 |
| Decision Date | 1983-10-27 |