510(k) K922765— BIOSTARS STREP A OIA -- MODIFICATION

Substantially Equivalent

Biosearch Medical Products, Inc.

Clearance details

Applicant: Biosearch Medical Products, Inc.
Product code: Code GTY
Advisory panel: Microbiology
Date received: 1992-06-02
Decision date: 1992-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

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.