PHASE II TSH KIT— 510(k) K832499

Substantially Equivalent

Medical & Scientific Designs, Inc.

FDA 510(k) clearance K832499 for PHASE II TSH KIT, Substantially Equivalent on 1983-09-12. Applicant: Medical & Scientific Designs, Inc..

Clearance details

Applicant: Medical & Scientific Designs, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1983-07-27
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.