FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
K Number: K072686
·
Decision Mar 17, 2008
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
24
Review Days
175
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Basic Information
- Device Name
- AXSYM HBA1C REAGENTS, AXSYM HBA1C CALIBRATORS, AXSYM HBA1C CONTROLS
- K Number
- K072686
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Axis-Shield Diagnostics, Ltd.
- Date Received
- September 24, 2007
- Decision Date
- March 17, 2008
- Product Code
- LCP
- Advisory Committee
- Hematology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCP | Assay, Glycosylated Hemoglobin | FDA class 2 | Hematology |
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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 |
| K083868 | ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 | Sep 25, 2009 | Substantially Equivalent |