UNIMARK HCG COMBO PREGNANCY TEST— 510(k) K013194

Substantially Equivalent

Biotech Atlantic, Inc.

FDA 510(k) clearance K013194 for UNIMARK HCG COMBO PREGNANCY TEST, Substantially Equivalent on 2001-10-10. Applicant: Biotech Atlantic, Inc..

Clearance details

Applicant: Biotech Atlantic, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2001-09-25
Decision date: 2001-10-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Eatontown, NJ, US

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Adverse events under product code JHI

product code JHI

Malfunction: 1,055
Total: 1,055

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.