K962060 is an FDA 510(k) clearance for the STREP A OIA MAX. This device is classified as a Antisera, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTZ).
Submitted by Biostar, Inc. (Boulder, US). The FDA issued a Cleared decision on July 23, 1997, 421 days after receiving the submission on May 28, 1996.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K962060 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 28, 1996 |
| Decision Date | July 23, 1997 |
| Days to Decision | 421 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | GTZ — Antisera, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |