Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2936856

FEI Number

2936856

Entity Name

Canon Medical Diagnostics USA, Inc.

City/State/Country

MOUNTAIN VIEW, CA, US

Establishment Address

630 Clyde Ct, MOUNTAIN VIEW, CA 94043, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Canon Medical Diagnostics USA, Inc. (Owner Number: 2936856)

Owner / Operator Contact Address

630 CLYDE CT., --, Mountain View, CA 94043, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K834526

PMA Number

N/A

All Registered Proprietary Names

AP 720S Semi-Automated Instrument CLA-1 Luminometer CLA Allergen Specific IgE Assay OPTIGEN Allergen Specific IgE Assay CLA Allergen Specific IgE Assay CLA Allergen Specific IgE Assay OPTIGEN US Food 16 OPTIGEN US Panel Control Reagent Kit OPTIGEN US Inhalant 36 OPTIGEN US Mix 36 OPTIGEN US Food 20 OPTIGEN US Food 25 OPTIGEN US Environmental 36 (100ND) OPTIGEN Environmental 36 (20T) OPTIGEN US Food 30 (100 ND) OPTIGEN Food 29 (20T) OPTIGEN Southern Express Panel I (40ND) CLA Allergen Specific IgE Assay OPTIGEN Food 20 OPTIGEN Korean Food OPTIGEN Alimenticio OPTIGEN Mix 30 OPTIGEN Inhalant 20 OPTIGEN Food 30 OPTIGEN Inhalant 36 #1 OPTIGEN Inhalant 30 OPTIGEN Korean Inhalant OPTIGEN Inhalatorio OPTIGEN Universal Panel 36 (Taiwan Panel) OPTIGEN ASEAN CLA Allergen Specific IgE Assay

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2013-01-04
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2007-12-18
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2007-12-18
DGC	Ige, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-18
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2007-12-18
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2007-12-18
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2007-12-18
PUW	System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens	Immunology	Class 2	866.5750	2017-12-06
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2007-12-18
PUW	System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens	Immunology	Class 2	866.5750	2023-07-20
DHB	System, Test, Radioallergosorbent (Rast) Immunological	Immunology	Class 2	866.5750	2007-12-18

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Canon Medical Diagnostics USA, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K874883	Incstar Corp.	WALNUT ALLERGEN DISC	1988-05-11
K935876	Bio-Rad Laboratories, Inc.	ACCESS SPECIFIC IGE ASSAY	1994-03-11
K093987	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 3G ALLERGY SPECIFIC IGE ASSAY KIT MODEL L2KUN6	2011-03-28
K132801	Siemens Healthcare Diagnostics, Inc.	IMMULITE 2000 SYSTEMS 3GALLERGY SPECIFIC IGE ASSAY	2014-05-28
K905612	Ventrex Laboratories, Inc.	VENTREX COATED TUBE IGE RADIOIMMUNOASSAY	1991-02-21

Similar Registrations

Registration Number	Establishment Name	Location
3039353646	PHADIA AB	Uppsala, SE
3002806944	SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LIMITED	LLANBERIS Wales, GB
2432235	Siemens Healthcare Diagnostics Inc.	Tarrytown, NY, US
9610566	PHADIA AB	UPPSALA, SE
3004973408	PHADIA US INC.	Portage, MI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2936856. Last updated year: 2026. Please use registration number 2936856 when referencing this establishment in official correspondence.