OPTICOAT T3 EIA KIT— 510(k) K981824

Substantially Equivalent

Biotecx Laboratories, Inc.

FDA 510(k) clearance K981824 for OPTICOAT T3 EIA KIT, Substantially Equivalent on 1998-12-22. Applicant: Biotecx Laboratories, Inc..

Clearance details

Applicant: Biotecx Laboratories, Inc.
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1998-05-22
Decision date: 1998-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, 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.