HYGEIA URINE PREGNANCY TEST— 510(k) K882192

Substantially Equivalent

Hygeia Sciences

FDA 510(k) clearance K882192 for HYGEIA URINE PREGNANCY TEST, Substantially Equivalent on 1988-11-10. Applicant: Hygeia Sciences.

Clearance details

Applicant: Hygeia Sciences
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1988-05-25
Decision date: 1988-11-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newton, MA, 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.