IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER— 510(k) K022603

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K022603 for IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER, Substantially Equivalent on 2002-08-21. Applicant: Diagnostic Products Corp..

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code CEW
Advisory panel: Clinical Chemistry
Date received: 2002-08-06
Decision date: 2002-08-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.