ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT

Device Classification Name

bromcresol green dye-binding, albumin

510(k) Number K131488
Device Name ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT
Applicant
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 henderson drive
west caldwell, 
NJ 
07006

Applicant Contact hyman katz
Correspondent
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC
4 henderson drive
west caldwell, 
NJ 
07006

Correspodent Contact hyman katz
Regulation Number 862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CEK   CJY  
Date Received 05/23/2013
Decision Date 08/19/2013
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