K032166 is an FDA 510(k) clearance for the BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065. This device is classified as a Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus (Class I - General Controls, product code GQG).
Submitted by Binax, Inc. (Portland, US). The FDA issued a Cleared decision on October 21, 2003, 97 days after receiving the submission on July 16, 2003.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3480.
| 510(k) Number | K032166 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2003 |
| Decision Date | October 21, 2003 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GQG — Antigen, Cf (including Cf Controls), Respiratory Syncytial Virus |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3480 |