SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)— 510(k) K011525

Substantially Equivalent

Biosafe Laboratories, Inc.

FDA 510(k) clearance K011525 for SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM), Substantially Equivalent on 2001-07-16. Applicant: Biosafe Laboratories, Inc..

Clearance details

Applicant: Biosafe Laboratories, Inc.
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 2001-05-17
Decision date: 2001-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, 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.