NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT— 510(k) K961650

Substantially Equivalent

Nichols Institute Diagnostics

FDA 510(k) clearance K961650 for NICHOLS ADVANTAGE CHEMILUMINESCENCE THYROID STIMULATING HORMONE THIRD GENERATION KIT, Substantially Equivalent on 1996-07-16. Applicant: Nichols Institute Diagnostics.

Clearance details

Applicant: Nichols Institute Diagnostics
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1996-04-30
Decision date: 1996-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Juan Capistrano, 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.