DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT— 510(k) K943150

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K943150 for DIRECT LDL CHOLESTEROL IMMUNOSEPARATION REAGENT KIT, Substantially Equivalent on 1995-03-15. Applicant: Genzyme Corp..

Clearance details

Applicant: Genzyme Corp.
Product code: Code MRR
Advisory panel: Clinical Chemistry
Date received: 1994-06-30
Decision date: 1995-03-15
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.