IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER— 510(k) K970227

Substantially Equivalent

Dpc Cirrus

FDA 510(k) clearance K970227 for IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER, Substantially Equivalent on 1997-04-08. Applicant: Dpc Cirrus.

Clearance details

Applicant: Dpc Cirrus
Product code: Code JJE
Advisory panel: Clinical Chemistry
Date received: 1997-01-17
Decision date: 1997-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randolph, NJ, US

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Adverse events under product code JJE

product code JJE

Death: 6
Injury: 441
Malfunction: 25,011
Other: 1
Total: 25,459

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.