The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Macconkey Agar W/mug, Dri-form And Pre-form.
Device ID | K862425 |
510k Number | K862425 |
Device Name: | MACCONKEY AGAR W/MUG, DRI-FORM AND PRE-FORM |
Classification | Culture Media, Selective And 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 | JSI |
CFR Regulation Number | 866.2360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-06-26 |
Decision Date | 1986-07-02 |