The following data is part of a premarket notification filed by Anaerobe Systems with the FDA for Anaerobic Brucella Laked Blood Agar.
Device ID | K791563 |
510k Number | K791563 |
Device Name: | ANAEROBIC BRUCELLA LAKED BLOOD AGAR |
Classification | Culture Media, Selective And Differential |
Applicant | ANAEROBE SYSTEMS 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-14 |
Decision Date | 1979-09-17 |