K951542 is an FDA 510(k) clearance for the DIRECTIGEN 1-2-3 GROUP A STREP TEST. This device is classified as a Antisera, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTZ).
Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Columbus, US). The FDA issued a Cleared decision on October 20, 1995, 200 days after receiving the submission on April 3, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K951542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1995 |
| Decision Date | October 20, 1995 |
| Days to Decision | 200 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTZ — Antisera, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |