BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST— 510(k) K892654

Substantially Equivalent

Princeton Biomedix

FDA 510(k) clearance K892654 for BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST, Substantially Equivalent on 1989-06-19. Applicant: Princeton Biomedix.

Clearance details

Applicant: Princeton Biomedix
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1989-04-13
Decision date: 1989-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerset, NJ, US

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.