CLINITEK HCG TEST STRIPS— 510(k) K971209

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K971209 for CLINITEK HCG TEST STRIPS, Substantially Equivalent on 1997-04-04. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1997-04-02
Decision date: 1997-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, 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.