K140354 is an FDA 510(k) clearance for the ABBOTT MULTI-COLLECT SPECIMEN COLLECTION KIT, ABBOTT REAL TIME CT/NG. This device is classified as a Dna-reagents, Neisseria (Class II - Special Controls, product code LSL).
Submitted by Abbott Molecular, Inc. (Des Plaines, US). The FDA issued a Cleared decision on May 9, 2014, 86 days after receiving the submission on February 12, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3390.
| 510(k) Number | K140354 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2014 |
| Decision Date | May 09, 2014 |
| Days to Decision | 86 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 |