K090737

Substantially Equivalent

HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI

Applicant: Bio-Rad Laboratories, Inc.
Product code: JKA
Advisory panel: Clinical Chemistry
Date received: 2009-03-20
Decision date: 2009-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hercules, CA, US

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Adverse events under product code JKA

product code JKA

Injury: 455
Malfunction: 26,686
Other: 4
Total: 27,145

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.