MICT TSH— 510(k) K110761

Substantially Equivalent

Magnabiosciences, LLC

FDA 510(k) clearance K110761 for MICT TSH, Substantially Equivalent on 2012-03-09. Applicant: Magnabiosciences, LLC.

Clearance details

Applicant: Magnabiosciences, LLC
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2011-03-18
Decision date: 2012-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.