The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Charcoal Agar Base.
Device ID | K861480 |
510k Number | K861480 |
Device Name: | CHARCOAL AGAR BASE |
Classification | Culture Media, Non-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 | JSG |
CFR Regulation Number | 866.2300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-04-22 |
Decision Date | 1986-05-06 |