BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST— 510(k) K023944

Substantially Equivalent

Bayer Corp.

FDA 510(k) clearance K023944 for BAYER DIAGNOSTICS CLINITEST PREGNANCY TEST, Substantially Equivalent on 2003-02-11. Applicant: Bayer Corp..

Clearance details

Applicant: Bayer Corp.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 2002-11-26
Decision date: 2003-02-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Medfield, MA, 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.