K935833 is an FDA 510(k) clearance for the LCX NEISSERIA GONORRHOEAE ASSAY. This device is classified as a Dna-reagents, Neisseria (Class II - Special Controls, product code LSL).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 6, 1996, 881 days after receiving the submission on December 7, 1993.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K935833 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 1993 |
| Decision Date | May 06, 1996 |
| Days to Decision | 881 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSL — Dna-reagents, Neisseria |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3390 |