K984631 is an FDA 510(k) clearance for the BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY. This device is classified as a Dna-reagents, Neisseria (Class II - Special Controls, product code LSL).
Submitted by Becton Dickinson Microbiology Systems (Sparks, US). The FDA issued a Cleared decision on November 4, 1999, 309 days after receiving the submission on December 30, 1998.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K984631 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 30, 1998 |
| Decision Date | November 04, 1999 |
| Days to Decision | 309 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 |