The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Precept Amoxicillin/clavvlanic Acid (augmentin).
| Device ID | K854577 |
| 510k Number | K854577 |
| Device Name: | PRECEPT AMOXICILLIN/CLAVVLANIC ACID (AUGMENTIN) |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Contact | Dennis R Schneider |
| Correspondent | Dennis R 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 | 1985-10-23 |
| Decision Date | 1986-02-05 |