DeviceClearance

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

Substantially Equivalent

Healgen Scientific,, LLC

Clearance details

Applicant
Healgen Scientific,, LLC
Product code
Code GTY
Advisory panel
Microbiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Bellaire, TX, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code GTY

product code GTY
Death
2
Total
2

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.