VISUAL SERUM/URINE HCG COMBO KIT— 510(k) K852437

Substantially Equivalent

American Bioclinical, Inc.

FDA 510(k) clearance K852437 for VISUAL SERUM/URINE HCG COMBO KIT, Substantially Equivalent on 1985-07-12. Applicant: American Bioclinical, Inc..

Clearance details

Applicant: American Bioclinical, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-06-10
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, 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.