DeviceClearance

K003752

Substantially Equivalent

BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)

Applicant
Biosafe Laboratories, Inc.
Product code
JLW
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Lake Forest, IL, 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, through . 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.