K864752 is an FDA 510(k) clearance for the ABBOTT TESTPACK(TM) STREP A POSITIVE CONTROL. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 26, 1987, 83 days after receiving the submission on December 5, 1986.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K864752 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 05, 1986 |
| Decision Date | February 26, 1987 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |