TSH - THIRD GENERATION LOW CONTROLS— 510(k) K924675

Substantially Equivalent

Nichols Institute

FDA 510(k) clearance K924675 for TSH - THIRD GENERATION LOW CONTROLS, Substantially Equivalent on 1992-11-18. Applicant: Nichols Institute.

Clearance details

Applicant: Nichols Institute
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 1992-09-16
Decision date: 1992-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, CA, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

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.