RIA QUANT B-HCG TEST KIT— 510(k) K781578

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K781578 for RIA QUANT B-HCG TEST KIT, Substantially Equivalent on 1978-10-10. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code JHI
Advisory panel: Clinical Chemistry
Date received: 1978-09-15
Decision date: 1978-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.