IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6— 510(k) K990222

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K990222 for IMMULITE HCG, MODEL LKCG1, LCCG5, IMMULITE 2000 HCG, MODEL L2KCG2, L2KCG6, Substantially Equivalent on 1999-02-26. Applicant: Diagnostic Products Corp..

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code DHA
Advisory panel: Clinical Chemistry
Date received: 1999-01-25
Decision date: 1999-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DHA

product code DHA

Malfunction: 1,242
Total: 1,242

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.