K852666 is an FDA 510(k) clearance for the IDENTICULT-AE. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).
Submitted by Scott Laboratories, Inc. (Fiskeville, US). The FDA issued a Cleared decision on July 15, 1985, 21 days after receiving the submission on June 24, 1985.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K852666 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1985 |
| Decision Date | July 15, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JTO — Discs, Strips And Reagents, Microorganism Differentiation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |