K913456 is an FDA 510(k) clearance for the VISI-NEISSERIA. This device is classified as a Kit, Identification, Neisseria Gonorrhoeae (Class I - General Controls, product code JSX).
Submitted by Kev Connecticut Diagnostics, Inc. (Danielson, US). The FDA issued a Cleared decision on October 11, 1991, 67 days after receiving the submission on August 5, 1991.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K913456 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 1991 |
| Decision Date | October 11, 1991 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | JSX — Kit, Identification, Neisseria Gonorrhoeae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |