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Alfa Wassermann Diagnostic Technologies, Inc.

FDA 510(k) & PMA Approved Devices — 21 products

Total Devices21
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K131975 ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTCFJ2013-10-02 View
510(k) K123953 ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTKHS2013-05-02 View
510(k) K123018 ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULECFR2013-04-23 View
510(k) K122757 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTCHH2012-10-05 View
510(k) K113389 ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENTCDN2012-08-10 View
510(k) K113437 ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENTLCP2012-08-06 View
510(k) K113374 ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENTCIX2012-07-13 View
510(k) K113262 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENTCHH2012-07-03 View
510(k) K113438 ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENTJMO2012-06-01 View
510(k) K113253 ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENTJJE2012-05-17 View
510(k) K112538 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENTCHH2012-03-29 View
510(k) K103615 ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARDCDN2011-09-08 View
510(k) K091711 S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023LCP2009-12-11 View
510(k) K083040 S-TEST C-REACTIVE PROTEIN (CRP)DCN2009-01-30 View
510(k) K082226 S40 CREATINE KINASE (CK)JHS2008-09-18 View
510(k) K072143 S40 CLINICAL ANALYZER, S TEST ALBCIX2008-07-14 View
510(k) K073223 S-TEST C02KHS2008-06-26 View
510(k) K072142 S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST ASTCKF2008-06-26 View
510(k) K072140 S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLUCFR2008-06-24 View
510(k) K072356 S-TEST CACJY2008-06-24 View
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