The following data is part of a premarket notification filed by Healgen Scientific, Llc with the FDA for Healgen Strep A Rapid Test Strip (throat Swab).
| Device ID | K212623 |
| 510k Number | K212623 |
| Device Name: | Healgen Strep A Rapid Test Strip (Throat Swab) |
| Classification | Antigens, All Groups, Streptococcus Spp. |
| Applicant | Healgen Scientific, LLC 5213 Maple St Bellaire, TX 77401 |
| Contact | Jianqiu Fang |
| Correspondent | Joe Shia LSI International Inc. 504 East Diamond Ave. Suite I Gaithersburg, MD 20877 |
| Product Code | GTY |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-18 |
| Decision Date | 2022-03-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00722066006849 | K212623 | 000 |