The following data is part of a premarket notification filed by Microline Scientific with the FDA for Selective Culture Med. Trichomonas.
Device ID | K841836 |
510k Number | K841836 |
Device Name: | SELECTIVE CULTURE MED. TRICHOMONAS |
Classification | Culture Media, Selective Broth |
Applicant | MICROLINE SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSD |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-04-17 |
Decision Date | 1984-05-14 |