Alfa Wassermann, Inc. — FDA Profile

Summary

Number	Class	Product	Date
Z-1530-2014	Class II	Alfa Wassermann Diagnostic Technologies, LLC. ACE AST Reagent. Product Usage: For quantitativ	March 5, 2014
Z-1529-2014	Class II	Alfa Wassermann Diagnostic Technologies, LLC. ACE ALT Reagent. Product Usage: For quantitativ	March 5, 2014
Z-0743-2013	Class II	Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann Diagnostic Technologies LL	October 10, 2012

K-Number	Device	Date
K131515	ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT	August 14, 2013
K113382	ACE ALT REAGENT	July 19, 2012
K113436	ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT	July 12, 2012
K113435	ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE M	July 2, 2012
K091413	S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCER	October 26, 2009
K091544	S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017	September 9, 2009
K091333	S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022	August 3, 2009
K080073	S-TEST CREATININE (CRE)	June 30, 2008
K063306	ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CO	April 17, 2007