Alfa Wassermann Diagnostic Technologies, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
23
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K170623ACE Hemoglobin A1c (HbA1c) ReagentFebruary 27, 2018
K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTOctober 2, 2013
K131351ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENTAugust 15, 2013
K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM May 2, 2013
K123018ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULEApril 23, 2013
K122757ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTOctober 5, 2012
K113389ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTAugust 10, 2012
K113437ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENTAugust 6, 2012
K113374ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGEJuly 13, 2012
K113262ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENTJuly 3, 2012
K113438ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTJune 1, 2012
K113253ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGMay 17, 2012
K112538ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTMarch 29, 2012
K103615ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. RESeptember 8, 2011
K091711S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023December 11, 2009
K083040S-TEST C-REACTIVE PROTEIN (CRP)January 30, 2009
K082226S40 CREATINE KINASE (CK)September 18, 2008
K072143S40 CLINICAL ANALYZER, S TEST ALBJuly 14, 2008
K073223S-TEST C02June 26, 2008
K072142S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST ASTJune 26, 2008