UNISTEP HCG PREGNANCY TEST STRIP— 510(k) K941090

Substantially Equivalent

Biotech Atlantic, Inc.

FDA 510(k) clearance K941090 for UNISTEP HCG PREGNANCY TEST STRIP, Substantially Equivalent on 1994-06-02. Applicant: Biotech Atlantic, Inc..

Clearance details

Applicant: Biotech Atlantic, Inc.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1994-03-08
Decision date: 1994-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eatontown, NJ, US

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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.