The following data is part of a premarket notification filed by Otisville Biotech, Inc. with the FDA for Cdc Anaerobe Blood Agar Plate.
Device ID | K834418 |
510k Number | K834418 |
Device Name: | CDC ANAEROBE BLOOD AGAR PLATE |
Classification | Culture Media, Non-selective And Non-differential |
Applicant | OTISVILLE BIOTECH, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-12-15 |
Decision Date | 1984-01-17 |