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. has 21 FDA 510(k) cleared chemistry devices. Based in West Caldwell, US.

Historical record: 21 cleared submissions from 2008 to 2013.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

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

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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