DC-3 FLUIDS PACK, DC-5 FLUIDS PACK— 510(k) K852595

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K852595 for DC-3 FLUIDS PACK, DC-5 FLUIDS PACK, Substantially Equivalent on 1985-07-12. Applicant: Diagnostic Chemicals, Ltd. (Usa).

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code JGS
Advisory panel: Clinical Chemistry
Date received: 1985-06-19
Decision date: 1985-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottestown,Pei,Canada, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code JGS

product code JGS

Malfunction: 535
Total: 535

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.