FDA 510(k) Applications Submitted by HYMAN KATZ
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K091333 |
05/06/2009 |
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 |
ALFA WASSERMANN, INC. |
| K131351 |
05/10/2013 |
ACE ALKALINE PHOSPHATASE REAGENT, AMYLASE REAGENT, ALT REAGENT, AST REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, LLC |
| K091413 |
05/13/2009 |
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) |
ALFA WASSERMANN, INC. |
| K131488 |
05/23/2013 |
ACE ALBUMIN REAGENT, ACE TOTAL PROTEIN REAGENT, ACE CALCIUM-ARSENAZO REAGENT AND ACE PHOSPHORUS REAGENT |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
| K091544 |
05/27/2009 |
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 |
ALFA WASSERMANN, 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. |
| K122302 |
08/01/2012 |
ACE MAGNESIUM REGENT |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
| 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. |
| K113382 |
11/16/2011 |
ACE ALT REAGENT |
ALFA WASSERMANN |
| K113389 |
11/16/2011 |
ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K113435 |
11/21/2011 |
ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
ALFA WASSERMANN |
| K113436 |
11/21/2011 |
ACE ALKALINE PHOSPHATASE REAGENT, ACE AMYLASE REAGENT, ACE LDH-L REAGENT |
ALFA WASSERMANN |
| 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. |
| K123322 |
10/26/2012 |
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT |
ALFA WASSERMANN DIAGNOSTICS TECHNOLOGIES, LLC |
| K123953 |
12/21/2012 |
ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENT |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
| K131515 |
05/28/2013 |
ACE -GT REAGENT; ACE LIPASE RAGENT; ACE T4 REAGENT |
ALFA WASSERMANN |
| 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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