Medical Device Manufacturer · US , West Caldwell , NJ

Alfa Wassermann Diagnostic Technologies, Inc. - FDA 510(k) Cleared De...

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

Alfa Wassermann Diagnostic Technologies, Inc. — FDA 510(k) Products and Clearance History Chemistry

21 devices
1-12 of 21
Cleared Oct 02, 2013
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON...
K131975 · CFJ
Chemistry · 96d
Cleared May 02, 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN...
K123953 · KHS
Chemistry · 132d
Cleared Apr 23, 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE...
K123018 · CFR
Chemistry · 207d
Cleared Oct 05, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K122757 · CHH
Chemistry · 28d
Cleared Aug 10, 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
K113389 · CDN
Chemistry · 268d
Cleared Aug 06, 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4...
K113437 · LCP
Chemistry · 259d
Cleared Jul 13, 2012
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT...
K113374 · CIX
Chemistry · 240d
Cleared Jul 03, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C,...
K113262 · CHH
Chemistry · 242d
Cleared Jun 01, 2012
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT,...
K113438 · JMO
Chemistry · 193d
Cleared May 17, 2012
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN...
K113253 · JJE
Chemistry · 197d
Cleared Mar 29, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
K112538 · CHH
Chemistry · 210d
Cleared Sep 08, 2011
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT,...
K103615 · CDN
Chemistry · 273d
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