K970009 is an FDA 510(k) clearance for the LYFO(TM) DIFFERENTIAL DISK-BACITRACIN. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).
Submitted by Microbiologics, Inc. (St. Cloud, US). The FDA issued a Cleared decision on February 6, 1997, 35 days after receiving the submission on January 2, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K970009 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 02, 1997 |
| Decision Date | February 06, 1997 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | JTO — Discs, Strips And Reagents, Microorganism Differentiation |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |