ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K112538
Device Name ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 henderson drive
west caldwell, 
NJ 
07006

Applicant Contact hyman katz
Correspondent
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 henderson drive
west caldwell, 
NJ 
07006

Correspodent Contact hyman katz
Regulation Number 862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CDT   LBS   MRR  
Date Received 09/01/2011
Decision Date 03/29/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No