FDA 510(k) Applications Submitted by Hitachi Chemical Diagnostics, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120369 |
02/06/2012 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K120945 |
03/29/2012 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K131217 |
04/30/2013 |
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K193613 |
12/26/2019 |
Allergen-Specific IgE Assay 12 Allergen Bundle |
Hitachi Chemical Diagnostics, Inc. |
| K182793 |
10/01/2018 |
AP3600 Automated Instrument |
Hitachi Chemical Diagnostics, Inc. |
| K112910 |
10/03/2011 |
AP 72OS SEMI-AUTOMATED INSTRUMENT |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K051677 |
06/21/2005 |
OPTIGEN ALLERGEN SPECIFIC IGE ASSAY |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K113809 |
12/23/2011 |
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K140248 |
01/30/2014 |
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K130685 |
03/13/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K130870 |
03/29/2013 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K131051 |
04/15/2013 |
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K132462 |
08/07/2013 |
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K130141 |
01/22/2013 |
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K111753 |
06/22/2011 |
HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
| K030590 |
02/25/2003 |
CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
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