DeviceClearance

K893953

Substantially Equivalent

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST

Applicant
Totem Diagnostics, Inc.
Product code
DHA
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Vancouver, B.C. V5z 4h5, CA
Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA
Malfunction
1,242
Total
1,242

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.