Hitachi Chemical Diagnostics, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Hitachi Chemical Diagnostics, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Allergen-Specific IgE Assay 12 Allergen Bundle, AP3600 Automated Instrument
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.
Regulatory submissions have been managed by Ammirati Regulatory Consulting and Minaris Medical.
FDA 510(k) Regulatory Record - Hitachi Chemical Diagnostics, Inc.
16 devices
Cleared
Oct 18, 2021
Allergen-Specific IgE Assay 12 Allergen Bundle
Immunology
662d
Cleared
Mar 19, 2019
AP3600 Automated Instrument
Immunology
169d
Cleared
Mar 11, 2014
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
Chemistry
40d
Cleared
Oct 28, 2013
S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
Chemistry
82d
Cleared
Aug 09, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY
Chemistry
149d
Cleared
Jun 07, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL...
Chemistry
435d
Cleared
Jun 07, 2013
HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB)
Chemistry
53d
Cleared
Jun 07, 2013
S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
Chemistry
38d
Cleared
May 02, 2013
HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA)
Chemistry
34d
Cleared
Mar 22, 2013
S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
Chemistry
59d
Cleared
Dec 20, 2012
AP 72OS SEMI-AUTOMATED INSTRUMENT
Immunology
444d
Cleared
Aug 17, 2012
HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
Immunology
238d