BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST— 510(k) K971349

Substantially Equivalent

Princeton BioMeditech Corp.

FDA 510(k) clearance K971349 for BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST, Substantially Equivalent on 1997-07-07. Applicant: Princeton BioMeditech Corp..

Clearance details

Applicant: Princeton BioMeditech Corp.
Product code: Code GTY
Advisory panel: Microbiology
Date received: 1997-04-10
Decision date: 1997-07-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monmouth Junction, NJ, US

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Adverse events under product code GTY

product code GTY

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 →

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