K092704 is an FDA 510(k) clearance for the ABBOTT REALTIME CT/NG AND ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, MODELS 8L07-91, 9K12-03. This device is classified as a Dna-reagents, Chlamydia (Class I - General Controls, product code LSK).
Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 28, 2010, 267 days after receiving the submission on September 3, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3120.
| 510(k) Number | K092704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 03, 2009 |
| Decision Date | May 28, 2010 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSK - Dna-reagents, Chlamydia |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3120 |