Medical Device Manufacturer · US , West Caldwell , NJ

Alfa Wassermann Diagnostic Technologies, Inc.

21 submissions · 21 cleared · Since 2008
21
Total
21
Cleared
0
Denied

Alfa Wassermann Diagnostic Technologies, Inc. — FDA 510(k) Submissions

Alfa Wassermann Diagnostic Technologies, Inc. has submitted 21 FDA 510(k) premarket notifications since 2008, of which 21 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Enzymatic Esterase--oxidase, Cholesterol, Bromcresol Green Dye-binding, Albumin, Enzymatic, Carbon-dioxide, Assay, Glycosylated Hemoglobin, Urease, Photometric, Urea Nitrogen . Use the specialty filter in the sidebar to narrow results.

21 devices
1–21 of 21
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT
K131975 · CFJ Nad Reduction/nadh... · Chemistry
Oct 2013 96d
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT
K123953 · KHS Enzymatic, Carbon-dioxide · Chemistry
May 2013 132d
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE
K123018 · CFR Hexokinase, Glucose · Chemistry
Apr 2013 207d
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
K122757 · CHH Enzymatic... · Chemistry
Oct 2012 28d
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN Urease, Photometric, Urea... · Chemistry
Aug 2012 268d
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT
K113437 · LCP Assay, Glycosylated... · Chemistry
Aug 2012 259d
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT
K113374 · CIX Bromcresol Green... · Chemistry
Jul 2012 240d
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT
K113262 · CHH Enzymatic... · Chemistry
Jul 2012 242d
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT
K113438 · JMO Ferrozine (colorimetric)... · Chemistry
Jun 2012 193d
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT
K113253 · JJE Analyzer, Chemistry... · Chemistry
May 2012 197d
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT
K112538 · CHH Enzymatic... · Chemistry
Mar 2012 210d
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
K103615 · CDN Urease, Photometric, Urea... · Chemistry
Sep 2011 273d
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
K091711 · LCP Assay, Glycosylated... · Chemistry
Dec 2009 184d
S-TEST C-REACTIVE PROTEIN (CRP)
K083040 · DCN System, Test, C-reactive... · Chemistry
Jan 2009 108d
S40 CREATINE KINASE (CK)
K082226 · JHS Differential Rate Kinetic... · Chemistry
Sep 2008 42d
S40 CLINICAL ANALYZER, S TEST ALB
K072143 · CIX Bromcresol Green... · Chemistry
Jul 2008 347d
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
K072142 · CKF Phenylphosphate, Alkaline... · Chemistry
Jun 2008 329d
S-TEST C02
K073223 · KHS Enzymatic, Carbon-dioxide · Chemistry
Jun 2008 224d
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
K072140 · CFR Hexokinase, Glucose · Chemistry
Jun 2008 327d
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
K072141 · CEO Phosphomolybdate... · Chemistry
Jun 2008 327d
S-TEST CA
K072356 · CJY Azo Dye, Calcium · Chemistry
Jun 2008 307d
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