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Alfa Wassermann Diagnostic Technologies, Inc.

21 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT (K131975)Alfa Wassermann Diagnostic Technologies, Inc.2013-10-02
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT (K123953)Alfa Wassermann Diagnostic Technologies, Inc.2013-05-02
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE (K123018)Alfa Wassermann Diagnostic Technologies, Inc.2013-04-23
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K122757)Alfa Wassermann Diagnostic Technologies, Inc.2012-10-05
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (K113389)Alfa Wassermann Diagnostic Technologies, Inc.2012-08-10
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT (K113437)Alfa Wassermann Diagnostic Technologies, Inc.2012-08-06
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT (K113374)Alfa Wassermann Diagnostic Technologies, Inc.2012-07-13
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT (K113262)Alfa Wassermann Diagnostic Technologies, Inc.2012-07-03
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT (K113438)Alfa Wassermann Diagnostic Technologies, Inc.2012-06-01
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT (K113253)Alfa Wassermann Diagnostic Technologies, Inc.2012-05-17
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT (K112538)Alfa Wassermann Diagnostic Technologies, Inc.2012-03-29
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD (K103615)Alfa Wassermann Diagnostic Technologies, Inc.2011-09-08
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 (K091711)Alfa Wassermann Diagnostic Technologies, Inc.2009-12-11
S-TEST C-REACTIVE PROTEIN (CRP) (K083040)Alfa Wassermann Diagnostic Technologies, Inc.2009-01-30
S40 CREATINE KINASE (CK) (K082226)Alfa Wassermann Diagnostic Technologies, Inc.2008-09-18
S40 CLINICAL ANALYZER, S TEST ALB (K072143)Alfa Wassermann Diagnostic Technologies, Inc.2008-07-14
S-TEST C02 (K073223)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-26
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST (K072142)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-26
S-TEST CA (K072356)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU (K072140)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA (K072141)Alfa Wassermann Diagnostic Technologies, Inc.2008-06-24

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Every clearance here is in the API, with alerts when new ones post.