The following data is part of a premarket notification filed by Gibco Laboratories Life Technologies, Inc. with the FDA for Aeromonas Agar(xdca).
| Device ID | K852789 |
| 510k Number | K852789 |
| Device Name: | AEROMONAS AGAR(XDCA) |
| 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 | 1985-07-01 |
| Decision Date | 1985-07-19 |