The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Precept Erythromycin.
| Device ID | K853053 |
| 510k Number | K853053 |
| Device Name: | PRECEPT ERYTHROMYCIN |
| Classification | Susceptibility Test Cards, Antimicrobial |
| 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 | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-19 |
| Decision Date | 1985-08-29 |