FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
K Number: K083868
·
Decision Sep 25, 2009
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
20
Applicant Total
24
Review Days
270
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Basic Information
- Device Name
- ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35
- K Number
- K083868
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5775
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Date Received
- December 29, 2008
- Decision Date
- September 25, 2009
- Product Code
- NHX
- 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 |
|---|---|---|---|
| NHX | Antibodies, Anti-Cyclic Citrullinated Peptide (Ccp) | FDA class 2 | Immunology |
Similar 510(k) Clearances
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| K121842 | ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C | Dec 12, 2012 | Substantially Equivalent |
| K112790 | AXIS-SHIELD 3-REAGENT HOMOCYSTEINE ASSAY FOR SYNCHRON | May 7, 2012 | Substantially Equivalent |
| K112443 | ARCHITECT ACTIVE B-12 (HOLOTRANSCOBALAMIN) | Dec 19, 2011 | Substantially Equivalent |
| K110296 | AXIS-SHIELD ANTI-CCP | Aug 18, 2011 | Substantially Equivalent |
| K083222 | AXIS-SHIELD LIQUID STABLE (LS) 2-PART HOMOCYSTEINE REAGENT, MODEL FHRK100 | Jul 31, 2009 | Substantially Equivalent |