Company ยท US
Hitachi Chemical Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2021. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 6 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 1 |
| DCN | System, Test, C-Reactive Protein | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JGQ | Turbidimetric, Total Protein | 1 |
| KHS | Enzymatic, Carbon-Dioxide | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2021 | K193613 | Allergen-Specific IgE Assay 12 Allergen Bundle Hitachi Chemical Diagnostics, Inc. | DHB |
| Mar 19, 2019 | K182793 | AP3600 Automated Instrument Hitachi Chemical Diagnostics, Inc. | DHB |
| Mar 11, 2014 | K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) Hitachi Chemical Diagnostics, Inc. | KHS |
| Oct 28, 2013 | K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE Hitachi Chemical Diagnostics, Inc. | CDN |
| Aug 9, 2013 | K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY Hitachi Chemical Diagnostics, Inc. | JFJ |
| Jun 7, 2013 | K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN Hitachi Chemical Diagnostics, Inc. | CIG |
| Jun 7, 2013 | K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) Hitachi Chemical Diagnostics, Inc. | JGQ |
| Jun 7, 2013 | K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST Hitachi Chemical Diagnostics, Inc. | CKA |
| May 2, 2013 | K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) Hitachi Chemical Diagnostics, Inc. | CIC |
| Mar 22, 2013 | K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) Hitachi Chemical Diagnostics, Inc. | CJE |
| Dec 20, 2012 | K112910 | AP 72OS SEMI-AUTOMATED INSTRUMENT Hitachi Chemical Diagnostics, Inc. | DHB |
| Aug 17, 2012 | K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) Hitachi Chemical Diagnostics, Inc. | DCN |
| May 10, 2012 | K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) Hitachi Chemical Diagnostics, Inc. | CFR |
| Dec 14, 2011 | K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE Hitachi Chemical Diagnostics, Inc. | CHH |
| Jan 23, 2006 | K051677 | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY Hitachi Chemical Diagnostics, Inc. | DHB |
| Mar 21, 2003 | K030590 | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) Hitachi Chemical Diagnostics, Inc. | DHB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2013 | Hitachi Chemical Diagnostics Inc OPTIGEN Food 30; Catalog number: 85035. For allergen testing.
Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA.
Distributed by Theridiag, Cedex, France Terminated |
DHB | K051677 |