EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST— 510(k) K970424

Substantially Equivalent

Excel Scientific, Inc.

FDA 510(k) clearance K970424 for EXCEL ONE STEP URINE HCG PREGNANCY DIPSTICK TEST, Substantially Equivalent on 1997-03-06. Applicant: Excel Scientific, Inc..

Clearance details

Applicant: Excel Scientific, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1997-02-04
Decision date: 1997-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Yorba Linda, CA, 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.