The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Dri-form Pseudomonas Agar F.
Device ID | K852064 |
510k Number | K852064 |
Device Name: | DRI-FORM PSEUDOMONAS AGAR F |
Classification | Culture Media, Non-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 | JSH |
CFR Regulation Number | 866.2320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-13 |
Decision Date | 1985-06-04 |