SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY)— 510(k) K962464

Substantially Equivalent

Scantibodies Laboratory, Inc.

FDA 510(k) clearance K962464 for SCANTIBODIES LABORATORY TSH IMMUNORADIOMETRIC ASSAY (IRMA)(COATED TUBE TECHNOLOGY), Substantially Equivalent on 1996-10-08. Applicant: Scantibodies Laboratory, Inc..

Clearance details

Applicant: Scantibodies Laboratory, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1996-06-25
Decision date: 1996-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santee, 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.