The following data is part of a premarket notification filed by Austin Biological Laboratories with the FDA for Precept Tm Amikacin.
| Device ID | K853686 |
| 510k Number | K853686 |
| Device Name: | PRECEPT TM AMIKACIN |
| Classification | Susceptibility Test Cards, Antimicrobial |
| 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 | LTW |
| CFR Regulation Number | 866.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-22 |
| Decision Date | 1985-09-13 |