ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR


Device Classification Name

ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl

510(k) Number K021316
Device Name ULTRA N-GENEOUS HDL CHOLESTEROL REAGENT 1/REAGENT2; ULTRA N-GENEOUS HDL CHOLESTREOL CALIBRATOR
Original Applicant
GENZYME CORP.
one kendall square
cambridge, 
MA 
02139

Original Contact barabra pizza
Regulation Number 862.1475
Classification Product Code
LBS  
Subsequent Product Code
JIS  
Date Received 04/25/2002
Decision Date 07/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No