The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Pseudomonas Agar P (medium A).
Device ID | K860750 |
510k Number | K860750 |
Device Name: | PSEUDOMONAS AGAR P (MEDIUM A) |
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 | 1986-02-28 |
Decision Date | 1986-03-10 |