K782013 is an FDA 510(k) clearance for the GONO-CELL. This device is classified as a Kit, Identification, Neisseria Gonorrhoeae (Class I - General Controls, product code JSX).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on April 23, 1979, 139 days after receiving the submission on December 5, 1978.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.
| 510(k) Number | K782013 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1978 |
| Decision Date | April 23, 1979 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | JSX — Kit, Identification, Neisseria Gonorrhoeae |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.2660 |