Alfa Wassermann, Inc. - FDA 510(k) Cleared Devices
Recent clearances: S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG), S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017, S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alfa Wassermann, Inc. Chemistry ✕
5 devices
Cleared
Oct 26, 2009
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL...
Chemistry
166d
Cleared
Sep 09, 2009
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017
Chemistry
105d
Cleared
Aug 03, 2009
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022
Chemistry
89d
Cleared
Jun 30, 2008
S-TEST CREATININE (CRE)
Chemistry
171d
Cleared
Apr 17, 2007
ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL...
Chemistry
167d