K081928 is an FDA 510(k) clearance for the D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT. This device is classified as a Respiratory Syncytial Virus, Antigen, Antibody, Ifa (Class I - General Controls, product code LKT).
Submitted by Diagnostic Hybrids, Inc. (Athens, US). The FDA issued a Cleared decision on December 23, 2008, 169 days after receiving the submission on July 7, 2008.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K081928 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2008 |
| Decision Date | December 23, 2008 |
| Days to Decision | 169 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LKT — Respiratory Syncytial Virus, Antigen, Antibody, Ifa |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |