Submission Details
| 510(k) Number | K212623 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Healgen Strep A Rapid Test Strip (Throat Swab)
Mar 2022
Decision
210d
Days
Class 1
Risk
About This 510(k) Submission
K212623 is an FDA 510(k) clearance for the Healgen Strep A Rapid Test Strip (Throat Swab), 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 review panel. Regulated under 21 CFR 866.3740.
Device Classification
| Product Code | GTY — Antigens, All Groups, Streptococcus Spp. |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 866.3740 |
Manufacturer
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