MIRCO ELISA HPL TEST KIT— 510(k) K921212

Substantially Equivalent

Bio Clinic Co.

FDA 510(k) clearance K921212 for MIRCO ELISA HPL TEST KIT, Substantially Equivalent on 1992-05-07. Applicant: Bio Clinic Co..

Clearance details

Applicant: Bio Clinic Co.
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1992-03-12
Decision date: 1992-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MI, US

Download summary PDF View on FDA.gov ↗

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.