T-3 MICROWELL EIA MODEL 7013— 510(k) K960412

Substantially Equivalent

Biomerica, Inc.

FDA 510(k) clearance K960412 for T-3 MICROWELL EIA MODEL 7013, Substantially Equivalent on 1996-03-19. Applicant: Biomerica, Inc..

Clearance details

Applicant: Biomerica, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1996-01-29
Decision date: 1996-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newport Beach, CA, US

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.