RIA-DAC TM HTSH KIH— 510(k) K770604

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K770604 for RIA-DAC TM HTSH KIH, Substantially Equivalent on 1977-04-06. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code JLW
Advisory panel: Clinical Chemistry
Date received: 1977-03-31
Decision date: 1977-04-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JLW

product code JLW

Malfunction: 885
Total: 885

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.