ABSOLUTE(TM)-HCG URINE PREGNANCY TEST— 510(k) K893953

Substantially Equivalent

Totem Diagnostics, Inc.

FDA 510(k) clearance K893953 for ABSOLUTE(TM)-HCG URINE PREGNANCY TEST, Substantially Equivalent on 1989-08-15. Applicant: Totem Diagnostics, Inc..

Clearance details

Applicant: Totem Diagnostics, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1989-06-01
Decision date: 1989-08-15
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, 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.