The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Cdc Anaerobic Sheep Blood Agar (ba).
Device ID | K791698 |
510k Number | K791698 |
Device Name: | CDC ANAEROBIC SHEEP BLOOD AGAR (BA) |
Classification | Culture Media, Non-selective And Non-differential |
Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, 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 | 1979-08-28 |
Decision Date | 1979-10-01 |