The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Pseudomonas Cepacia Selective Agar, Dri & Pre-form.
| Device ID | K864755 |
| 510k Number | K864755 |
| Device Name: | PSEUDOMONAS CEPACIA SELECTIVE AGAR, DRI & PRE-FORM |
| 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 | 1986-12-05 |
| Decision Date | 1987-01-05 |