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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzymatic esterase--oxidase, cholesterol
510(k) Number K122757
Model SA1010, RX1010, SA1043, SA2038, RX2038, SA1040, RX1026, SA1023, RX1023
Device Name ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
Original Applicant
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
4 henderson drive
west caldwell,  NJ  07006
Original Contact hyman katz, ph.d.
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CDT   LBS   MRR  
Date Received09/07/2012
Decision Date 10/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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