The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Precept(tm) Ciprofloxacin.
| Device ID | K874727 |
| 510k Number | K874727 |
| Device Name: | PRECEPT(TM) CIPROFLOXACIN |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Contact | Ray Schneider |
| Correspondent | Ray Schneider AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Product Code | JWY |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-18 |
| Decision Date | 1988-02-18 |