K945571 is an FDA 510(k) clearance for the ABBOTT TEST PACK STREP A TEST. This device is classified as a Antisera, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTZ).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on August 14, 1995, 280 days after receiving the submission on November 7, 1994.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K945571 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 07, 1994 |
| Decision Date | August 14, 1995 |
| Days to Decision | 280 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 |