Data / Medical devices / United States / Canon Medical Diagnostics USA, Inc.
Canon Medical Diagnostics USA, Inc.: FDA-registered device maker in Mountain View, CA, United States, 11 510(k) clearances
Canon Medical Diagnostics USA, Inc. is registered with the FDA (registration 2936856) in Mountain View, CA, United States. It lists 3 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 19, 2019. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2936856
- Address
- 630 Clyde Ct, Mountain View, CA, United States, 94043
- Owner or operator
- Canon Medical Diagnostics USA, Inc. (2936856)
- Roles
- Manufacturer, Manufacturer for export, Specification developer
- First device listed
- December 18, 2007
- Registered through
- 2027
- Brand names listed
- AP 720S Semi-Automated Instrument, AP3600 Automated Instrument, CLA Allergen Specific IgE Assay, CLA negative control sera, CLA positive control sera, CLA-1 Luminometer, OPTIGEN ASEAN, OPTIGEN Alimenticio and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Ige, Antigen, Antiserum, Control | DGC | 2 | Manufacturer | accessdata.fda.gov |
| System, Test, Radioallergosorbent (Rast) Immunological | DHB | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens | PUW | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 19, 2019 | K182793 | AP3600 Automated Instrument | DHB | Substantially Equivalent | Hitachi Chemical Diagnostics, Inc. | accessdata.fda.gov |
| December 20, 2012 | K112910 | AP 72OS SEMI-AUTOMATED INSTRUMENT | DHB | Substantially Equivalent | Hitachi Chemical Diagnostics, Inc. | accessdata.fda.gov |
| January 23, 2006 | K051677 | OPTIGEN ALLERGEN SPECIFIC IGE ASSAY | DHB | Substantially Equivalent | Hitachi Chemical Diagnostics, Inc. | accessdata.fda.gov |
| March 7, 1994 | K934524 | MAST CLA ALLERGY SYSTEM | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
| March 7, 1994 | K926420 | MAST CLA ALLERGY SYSTEM | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
| December 9, 1991 | K914850 | CHEMILUMINESCENT SYSTEM ALLERGAN SPECIFIC IGE | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
| April 5, 1991 | K910292 | MAST CLA ALLERGY SYSTEM | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
| April 12, 1985 | K843694 | MAST ALLERGY SYSTEM | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
| April 4, 1984 | K834526 | MAST INHALANT PROFILE | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
| January 4, 1984 | K833885 | MAST INHALANT PROFILE | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
| February 25, 1983 | K823593 | INHALANT PROFILE-ALLERGEN-SPECIFIC IGE | DHB | Substantially Equivalent | Mast Immunosystems | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| December 21, 2012 | 64132 | Class III | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Test, Radioallergosorbent (Rast) Immunological
- All makers of Ige, Antigen, Antiserum, Control
- All makers of System, Test, Radioallergosorbent (Rast) Immunological, Exempt Allergens
Updated March 19, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.