Alfa Wassermann Diagnostic Technologies, Inc. - FDA 510(k) Cleared De...
21
Total
21
Cleared
0
Denied
Alfa Wassermann Diagnostic Technologies, Inc. — FDA 510(k) Products and Clearance History Chemistry ✕
21 devices
Cleared
Oct 02, 2013
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON...
Chemistry
96d
Cleared
May 02, 2013
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN...
Chemistry
132d
Cleared
Apr 23, 2013
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE...
Chemistry
207d
Cleared
Oct 05, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
Chemistry
28d
Cleared
Aug 10, 2012
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
Chemistry
268d
Cleared
Aug 06, 2012
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4...
Chemistry
259d
Cleared
Jul 13, 2012
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT...
Chemistry
240d
Cleared
Jul 03, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C,...
Chemistry
242d
Cleared
Jun 01, 2012
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT,...
Chemistry
193d
Cleared
May 17, 2012
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN...
Chemistry
197d
Cleared
Mar 29, 2012
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE...
Chemistry
210d
Cleared
Sep 08, 2011
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT,...
Chemistry
273d
Cleared
Dec 11, 2009
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023
Chemistry
184d
Cleared
Jan 30, 2009
S-TEST C-REACTIVE PROTEIN (CRP)
Chemistry
108d
Cleared
Sep 18, 2008
S40 CREATINE KINASE (CK)
Chemistry
42d
Cleared
Jul 14, 2008
S40 CLINICAL ANALYZER, S TEST ALB
Chemistry
347d
Cleared
Jun 26, 2008
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST
Chemistry
329d
Cleared
Jun 26, 2008
S-TEST C02
Chemistry
224d
Cleared
Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU
Chemistry
327d
Cleared
Jun 24, 2008
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA
Chemistry
327d
Cleared
Jun 24, 2008
S-TEST CA
Chemistry
307d