ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES— 510(k) K872130

Substantially Equivalent

Syva Co.

FDA 510(k) clearance K872130 for ACCUPOINT HCG PREGNANCY TEST AND ACCESSORIES, Substantially Equivalent on 1987-07-16. Applicant: Syva Co..

Clearance details

Applicant: Syva Co.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1987-06-02
Decision date: 1987-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Palo Alto, 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.