K853686 is an FDA 510(k) clearance for the PRECEPT TM AMIKACIN. This device is classified as a Susceptibility Test Cards, Antimicrobial (Class II - Special Controls, product code LTW).
Submitted by Austin Biological Laboratories (Austin, US). The FDA issued a Cleared decision on September 13, 1985, 175 days after receiving the submission on March 22, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.1640.
| 510(k) Number | K853686 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1985 |
| Decision Date | September 13, 1985 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LTW — Susceptibility Test Cards, Antimicrobial |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.1640 |