The following data is part of a premarket notification filed by Microline Scientific with the FDA for Selective Culture Med. Selective Strep.
Device ID | K841839 |
510k Number | K841839 |
Device Name: | SELECTIVE CULTURE MED. SELECTIVE STREP |
Classification | Culture Media, Selective And Non-differential |
Applicant | MICROLINE SCIENTIFIC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSJ |
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 | 1984-05-25 |