Healgen Strep A Rapid Test Strip (Throat Swab)— 510(k) K212623

Clearance details

Applicant

Healgen Scientific,, LLC

Product code

Code GTY

Device class

Class 1

Regulation

21 CFR 866.3740

Advisory panel

Microbiology

Date received

2021-08-18

Decision date

2022-03-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Bellaire, TX, US

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Death

2

Total

2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →