Canon Medical Diagnostics USA, Inc.
Mountain View, CA, US
Canon Medical Diagnostics USA, Inc. appears in FDA device records in Mountain View, CA. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Canon Medical Diagnostics USA, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Hitachi Chemical Diagnostics, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 16 510(k) clearances for Canon Medical Diagnostics USA, Inc. between 2003 and 2021. The busiest year on record is 2013, with 7. The most recent is 2021, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2006 | 1 |
| 2011 | 1 |
| 2012 | 3 |
| 2013 | 7 |
| 2014 | 1 |
| 2019 | 1 |
| 2021 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K193613 | Allergen-Specific IgE Assay 12 Allergen Bundle | DHB | Substantially Equivalent | |
| K182793 | AP3600 Automated Instrument | DHB | Substantially Equivalent | |
| K140248 | S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) | KHS | Substantially Equivalent | |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | CDN | Substantially Equivalent | |
| K130685 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGES FOR LD AND AMY | JFJ | Substantially Equivalent | |
| K131217 | S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN | CIG | Substantially Equivalent | |
| K131051 | HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) | JGQ | Substantially Equivalent | |
| K120945 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST | CKA | Substantially Equivalent | |
| K130870 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE CALCIUM (CA) | CIC | Substantially Equivalent | |
| K130141 | S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE) | CJE | Substantially Equivalent | |
| K112910 | AP 72OS SEMI-AUTOMATED INSTRUMENT | DHB | Substantially Equivalent | |
| K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP) | DCN | Substantially Equivalent | |
| K120369 | HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE GLUCOSE (GLU) | CFR | Substantially Equivalent | |
| K111753 | HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE | CHH | Substantially Equivalent | |
| K051677 | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY | DHB | Substantially Equivalent | |
| K030590 | CLA ALLERGEN-SPECIFIC IGE ASSAY-LATEX ALLERGEN (K82) | DHB | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2936856 | 2936856 | Canon Medical Diagnostics USA, Inc. | 630 Clyde Ct, MOUNTAIN VIEW, CA 94043 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JFJCatalytic Methods, Amylase
- CICCresolphthalein Complexone, Calcium
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- CFRHexokinase, Glucose
- DGCIge, Antigen, Antiserum, Control
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- DCNSystem, Test, C-Reactive Protein
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- PUWSystem, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
- JGQTurbidimetric, Total Protein
- CDNUrease, Photometric, Urea Nitrogen
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0793-2013 | OPTIGEN Food 30; Catalog number: 85035. For allergen testing. Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France | There is no evidence that a visual inspection was performed on one tray of coverslips. Possibility of a low fill volume which could lead to a false negative results. | Class III | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Canon Medical Diagnostics USA, Inc. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain