OSOM HCG-URINE TEST MODEL 101— 510(k) K974159

Substantially Equivalent

Wyntek Diagnostics, Inc.

FDA 510(k) clearance K974159 for OSOM HCG-URINE TEST MODEL 101, Substantially Equivalent on 1997-12-24. Applicant: Wyntek Diagnostics, Inc..

Clearance details

Applicant: Wyntek Diagnostics, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1997-10-14
Decision date: 1997-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, 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.