STREP B OIA— 510(k) K991828

Name: FDA 510(k) clearance K991828
Creator: U.S. Food and Drug Administration
Published: 1999-08-19

Substantially Equivalent

Biostar, Inc.

FDA 510(k) clearance K991828 for STREP B OIA, Substantially Equivalent on 1999-08-19. Applicant: Biostar, Inc.. Device class: 1.

Clearance details

Applicant: Biostar, Inc.
Product code: Code GTY
Device class: Class 1
Regulation: 21 CFR 866.3740
Advisory panel: Microbiology
Date received: 1999-05-28
Decision date: 1999-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

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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.