Medical Device Manufacturer · US , Mountain View , CA

Hitachi Chemical Diagnostics, Inc. - FDA 510(k) Cleared Devices

16 submissions · 16 cleared · Since 2003
16
Total
16
Cleared
0
Denied

Hitachi Chemical Diagnostics, Inc. has 16 FDA 510(k) cleared medical devices. Based in Mountain View, US.

Last cleared in 2021. Active since 2003. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Hitachi Chemical Diagnostics, Inc. Filter by specialty or product code using the sidebar.

16 devices
1–12 of 16
Allergen-Specific IgE Assay 12 Allergen Bundle
K193613 · DHB System, Test, Radioallergosorbent (rast) Immunological · Immunology
Oct 2021 662d
AP3600 Automated Instrument
K182793 · DHB System, Test, Radioallergosorbent (rast) Immunological · Immunology
Mar 2019 169d
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
K140248 · KHS Enzymatic, Carbon-dioxide · Chemistry
Mar 2014 40d
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
K132462 · CDN Urease, Photometric, Urea Nitrogen · Chemistry
Oct 2013 82d
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
K130685 · JFJ Catalytic Methods, Amylase · Chemistry
Aug 2013 149d
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST
K120945 · CKA Nadh Oxidation/nad Reduction, Alt/sgpt · Chemistry
Jun 2013 435d
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
K131051 · JGQ Turbidimetric, Total Protein · Chemistry
Jun 2013 53d
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
K131217 · CIG Diazo Colorimetry, Bilirubin · Chemistry
Jun 2013 38d
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
K130870 · CIC Cresolphthalein Complexone, Calcium · Chemistry
May 2013 34d
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
K130141 · CJE Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes · Chemistry
Mar 2013 59d
AP 72OS SEMI-AUTOMATED INSTRUMENT
K112910 · DHB System, Test, Radioallergosorbent (rast) Immunological · Immunology
Dec 2012 444d
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
K113809 · DCN System, Test, C-reactive Protein · Immunology
Aug 2012 238d
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