510(k) Premarket Notification

• 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
• Applicant: ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.; 4 henderson drive; west caldwell, NJ 07006
• Contact: hyman katz, ph.d.
• Regulation Number: 862.1175
• Classification Product Code: CHH
• Subsequent Product Codes: CDT LBS MRR
• Date Received: 09/07/2012
• 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