The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Phenylethyl Alcohol Blood Agar.
Device ID | K841140 |
510k Number | K841140 |
Device Name: | PHENYLETHYL ALCOHOL BLOOD AGAR |
Classification | Culture Media, Selective And Non-differential |
Applicant | ANAEROBE SYSTEMS 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 | 1984-03-16 |
Decision Date | 1984-03-26 |