ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.— 510(k) K052694

Substantially Equivalent

Ind Diagnostic, Inc.

FDA 510(k) clearance K052694 for ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES., Substantially Equivalent on 2005-12-16. Applicant: Ind Diagnostic, Inc..

Clearance details

Applicant: Ind Diagnostic, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2005-09-28
Decision date: 2005-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Delta, B.C., CA

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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.