DAC-CEL TSH— 510(k) K810213

Substantially Equivalent

Burroughs Wellcome Co.

FDA 510(k) clearance K810213 for DAC-CEL TSH, Substantially Equivalent on 1981-02-10. Applicant: Burroughs Wellcome Co..

Clearance details

Applicant: Burroughs Wellcome Co.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1981-01-27
Decision date: 1981-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.