OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM— 510(k) K062581

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K062581 for OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM, Substantially Equivalent on 2006-11-29. Applicant: Olympus America, Inc..

Clearance details

Applicant: Olympus America, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2006-08-31
Decision date: 2006-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irving, TX, 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.