THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST— 510(k) K961629

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K961629 for THYROID STIUMLATING HORMONE (TSH-BEADS ASSAY) TEST, Substantially Equivalent on 1996-09-11. Applicant: Teco Diagnostics.

Clearance details

Applicant: Teco Diagnostics
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1996-04-26
Decision date: 1996-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, 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.