MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT— 510(k) K925436

Name: FDA 510(k) clearance K925436
Creator: U.S. Food and Drug Administration
Published: 1992-12-28

Substantially Equivalent

Medix Biotech, Inc.

FDA 510(k) clearance K925436 for MEDIX BIOTECH TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, Substantially Equivalent on 1992-12-28. Applicant: Medix Biotech, Inc.. Device class: 2.

Clearance details

Applicant: Medix Biotech, Inc.
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1992-10-28
Decision date: 1992-12-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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K981824 — OPTICOAT T3 EIA KIT1998-12-22

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K932758 — MEDIX BIOTECH BESTEST HCG-URINE TEST KIT1993-09-28
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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.