ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR— 510(k) K021316

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K021316 for ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR, Substantially Equivalent on 2002-07-25. Applicant: Genzyme Corp..

Clearance details

Applicant: Genzyme Corp.
Product code: Code LBS
Advisory panel: Clinical Chemistry
Date received: 2002-04-25
Decision date: 2002-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.