TSH-STAT— 510(k) K844583

Substantially Equivalent

Nuclear Medical Laboratories, Inc.

FDA 510(k) clearance K844583 for TSH-STAT, Substantially Equivalent on 1985-03-05. Applicant: Nuclear Medical Laboratories, Inc..

Clearance details

Applicant: Nuclear Medical Laboratories, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1984-11-23
Decision date: 1985-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, US

Download summary PDF View on FDA.gov ↗

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.