TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093— 510(k) K921700

Substantially Equivalent

Medix Biotech, Inc.

FDA 510(k) clearance K921700 for TSH ENZYME IMMUNOASSAY TEST KIT CAT. NO. KIF4093, Substantially Equivalent on 1992-06-29. Applicant: Medix Biotech, Inc..

Clearance details

Applicant: Medix Biotech, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1992-04-08
Decision date: 1992-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

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Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.