MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO— 510(k) K854059

Substantially Equivalent

Bioclinical Systems, Inc.

FDA 510(k) clearance K854059 for MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO, Substantially Equivalent on 1986-01-13. Applicant: Bioclinical Systems, Inc..

Clearance details

Applicant: Bioclinical Systems, Inc.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1985-10-03
Decision date: 1986-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Louis, MO, 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.