The following data is part of a premarket notification filed by Microline Scientific with the FDA for Enriched Culture Med. Tryptic Soy Agar.
| Device ID | K841838 |
| 510k Number | K841838 |
| Device Name: | ENRICHED CULTURE MED. TRYPTIC SOY AGAR |
| Classification | Culture Media, Enriched |
| Applicant | MICROLINE SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KZI |
| CFR Regulation Number | 866.2330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-17 |
| Decision Date | 1984-05-21 |