The following data is part of a premarket notification filed by Fairleigh Dickinson Laboratories, Inc. with the FDA for Brewer Gel For Campylobacter.
| Device ID | K881502 |
| 510k Number | K881502 |
| Device Name: | BREWER GEL FOR CAMPYLOBACTER |
| Classification | Device, Gas Generating |
| Applicant | FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Contact | Mark Randel |
| Correspondent | Mark Randel FAIRLEIGH DICKINSON LABORATORIES, INC. 1249 AMBLER AVE. Abilene, TX 79601 |
| Product Code | KZJ |
| CFR Regulation Number | 866.2580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-04-27 |