The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Precept Ceftizoxime.
| Device ID | K862560 |
| 510k Number | K862560 |
| Device Name: | PRECEPT CEFTIZOXIME |
| Classification | Manual Antimicrobial Susceptibility Test Systems |
| Applicant | AUSTIN BIOLOGICAL LABORATORIES 6620-A MANOR RD. Austin, TX 78723 |
| Contact | Dennis Schneider,phd |
| Correspondent | Dennis Schneider,phd 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 | 1986-07-03 |
| Decision Date | 1986-07-11 |