BIONIKE A/Q PREGNANCY TEST— 510(k) K951136

Substantially Equivalent

Charlton Assoc.

FDA 510(k) clearance K951136 for BIONIKE A/Q PREGNANCY TEST, Substantially Equivalent on 1995-04-20. Applicant: Charlton Assoc..

Clearance details

Applicant: Charlton Assoc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1995-03-13
Decision date: 1995-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, 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.