The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Campylobacter Cva Agar.
Device ID | K860862 |
510k Number | K860862 |
Device Name: | CAMPYLOBACTER CVA AGAR |
Classification | Culture Media, Selective And Non-differential |
Applicant | GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
Contact | Gregg G Burmeister |
Correspondent | Gregg G Burmeister GIBCO LABORATORIES LIFE TECHNOLOGIES, INC. 2801 INDUSTRIAL DR. Madison, WI 53713 |
Product Code | JSJ |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-03-07 |
Decision Date | 1986-03-18 |