K212623 is an FDA 510(k) clearance for the Healgen Strep A Rapid Test Strip (Throat Swab). This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I - General Controls, product code GTY).
Submitted by Healgen Scientific, LLC (Bellaire, US). The FDA issued a Cleared decision on March 16, 2022, 210 days after receiving the submission on August 18, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.
| 510(k) Number | K212623 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2021 |
| Decision Date | March 16, 2022 |
| Days to Decision | 210 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 866.3740 |