FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
K Number: K081615
·
Decision Mar 18, 2009
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
27
Applicant Total
149
Review Days
282
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Basic Information
- Device Name
- OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN
- K Number
- K081615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.6010
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Olympus America, Inc.
- Date Received
- June 9, 2008
- Decision Date
- March 18, 2009
- Product Code
- DHX
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DHX | System, Test, Carcinoembryonic Antigen | FDA class 2 | Immunology |
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|---|---|---|---|
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| K073487 | OLYMPUS IGM REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073490 | OLYMPUS IGG REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K073489 | OLYMPUS IGA REAGENT | Feb 11, 2008 | Substantially Equivalent |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Apr 6, 2007 | Substantially Equivalent |
| K063804 | OLYMPUS TRIGLYCERIDE TEST SYSTEM | Mar 23, 2007 | Substantially Equivalent |
| K061499 | OSFERION | Jan 26, 2007 | Substantially Equivalent |
| K062581 | OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMUNOASSAY SYSTEM | Nov 29, 2006 | Substantially Equivalent |
| K061575 | OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR65117 | Oct 5, 2006 | Substantially Equivalent |
| K060201 | OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. | Jun 6, 2006 | Substantially Equivalent |