FDA 510(k) Applications Submitted by ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K072140 |
08/02/2007 |
S40 CLINICAL ANALYZER, S TEST BIL, S TEST BUN, S TEST GLU |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K072141 |
08/02/2007 |
S40 CLINICAL ANALYZER, S TEST IP, S TEST UA |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K072142 |
08/02/2007 |
S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST AST |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K072143 |
08/02/2007 |
S40 CLINICAL ANALYZER, S TEST ALB |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K072356 |
08/22/2007 |
S-TEST CA |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K073223 |
11/15/2007 |
S-TEST C02 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K082226 |
08/07/2008 |
S40 CREATINE KINASE (CK) |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K083040 |
10/14/2008 |
S-TEST C-REACTIVE PROTEIN (CRP) |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K091711 |
06/10/2009 |
S- TEST HEMOGLOBIN ALC (HBA1C), MODEL RC0023 |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K131975 |
06/28/2013 |
ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K112538 |
09/01/2011 |
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K113253 |
11/02/2011 |
ACE AXCEL CLINICAL CHEMISTRY SYSTEM,ACE ALBUMIN REAGENT,ACE TOTAL PROTEIN REAGENT,ACE BUN/UREANITROGEN REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K113262 |
11/04/2011 |
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT-C, ACE-TRISLYCERIDES REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K113374 |
11/16/2011 |
ACE ALBUMIN REAGENT ACE TOTAL PROTEIN REAGENT ACE CALCIUM-ARSENAZO REAGENT ACE PHOSPHORUS U.V. REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K113389 |
11/16/2011 |
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K113437 |
11/21/2011 |
ACE HEMOGLOBIN ALC(HBALC) REAGENT, ACE CEDIA T UPTAKE REAGENT, ACE T4 REAGENT, ACE FERRITIN REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K113438 |
11/21/2011 |
ACE DIRECT TOTALIRON-BINDING CAPACITY (TIBC) REAGENT, ACE SERUM IRON REAGENT, ACE LIPASE REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K103615 |
12/09/2010 |
ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K123018 |
09/28/2012 |
ACE ALERA CLINICAL CHEMISTRY SYSTEM, ACE GLUCOSE REAGENT, ACE ION SELECTIVE ELECTRODE (ISE) MODULE |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K123953 |
12/21/2012 |
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K122757 |
09/07/2012 |
ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
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