K971349 is an FDA 510(k) clearance for the BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by Princeton BioMeditech Corp. (Monmouth Junction, US). The FDA issued a Cleared decision on July 7, 1997, 88 days after receiving the submission on April 10, 1997.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K971349 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 1997 |
| Decision Date | July 07, 1997 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |