TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005— 510(k) K991311

Substantially Equivalent

Biocheck, Inc.

FDA 510(k) clearance K991311 for TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005, Substantially Equivalent on 1999-06-02. Applicant: Biocheck, Inc..

Clearance details

Applicant: Biocheck, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1999-04-16
Decision date: 1999-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northridge, 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.