FDA 510(k) Applications Submitted by HYMAN KATZ PH.D.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| 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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