K961191 is an FDA 510(k) clearance for the COLISCREEN. This device is classified as a Discs, Strips And Reagents, Microorganism Differentiation (Class I - General Controls, product code JTO).
Submitted by Hardy Diagnostics (Santa Maria, US). The FDA issued a Cleared decision on June 17, 1996, 83 days after receiving the submission on March 26, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K961191 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 1996 |
| Decision Date | June 17, 1996 |
| Days to Decision | 83 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 |