This page includes the latest FDA filings for Hitachi Chemical Diagnostics Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Hitachi Chemical Diagnostics Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 2936856 |
| FEI Number | 2936856 |
| Name | HITACHI CHEMICAL DIAGNOSTICS, INC. |
| Owner & Operator | HITACHI CHEMICAL DIAGNOSTICS, INC. |
| Contact Address | 630 CLYDE CT. -- Mountain View CA 94043 US |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 630 CLYDE CT. MOUNTAIN VIEW, CA 94043 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) 85066 | 2019-05-30 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND) 85082 | 2019-05-30 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36(100 ND) 85081 | 2019-05-30 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® AP 3600™ Automated Instrument 95413 | 2019-05-30 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | AP3600 Automated Instrument | 2019-03-19 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - US Mix 36 Panel 85065 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - US Food 20 Panel 85064 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - US Inhalant 36 Panel 85063 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | UP20 Negative Control Reagent 80108 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Eastern 84508 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | UP20 Positive Control Reagent 80107 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | AP 720S™ Semi-Automated Processor 93602 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Positive Control Serum 93026 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Negative Control Serum 94173 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Moderate Food Panel 84518 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Western Inhalant Panel 84511 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Southwestern Inhalant Panel 84509 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Southeastern Inhalant Panel 84507 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Pediatric Comprehensive Panel 84506 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Northwestern Inhalant Panel 84505 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Eastern 84502 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Negative Control Reagent 82062 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Positive Control Reagent 82061 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel 85003 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® Allergen-Specific IgE Assay - Universal 20 Panel 85003 | 2018-07-06 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN® US Panel Control Reagent 80109 | 2018-03-29 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA® Allergen-Specific IgE Assay - Northeastern Inhalant Panel 84504 | 2018-03-29 |
| HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA-1™ Luminometer 95019 | 2018-03-29 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN US Panel Control Reagent Kit | 2017-12-06 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN US Mix 36 | 2017-12-06 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN US Inhalant 36 | 2017-12-06 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN US Food 25 | 2017-12-06 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN US Food 20 | 2017-12-06 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | 2014-03-11 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | 2013-10-28 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN Mexicano Inhalatorio | 2013-09-13 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN Alimenticio Mexicano | 2013-09-13 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Mexicano Inhalatorio | 2013-09-13 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Alimenticio Mexicano | 2013-09-13 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | 2013-08-09 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | 2013-06-07 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | 2013-06-07 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | 2013-06-07 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | 2013-05-02 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | 2013-03-22 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | AP 720S Semi-Automated Instrument | 2013-01-04 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | AP 72OS SEMI-AUTOMATED INSTRUMENT | 2012-12-20 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | 2012-08-17 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | 2012-05-10 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE | 2011-12-14 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA-1 Luminometer | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA positive control sera | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA negative control sera | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA Allergen Specific IgE Assay | 2007-12-18 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY | 2006-01-23 |
HITACHI CHEMICAL DIAGNOSTICS, INC. | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) | 2003-03-21 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 2020091774398 | Tokyo ,Japan -> Oakland, California | MECHANO-THERAPY APPLIANCES HS CODE:901910 10 CASES | 10 CAS |
| 2020052942794 | Tokyo ,Japan -> Los Angeles, California | MECHANO-THERAPY APPLIANCES HS CODE:901910 5 CARTONS | 5 CTN |