FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
K Number: K073309
·
Decision Oct 17, 2008
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
19
Review Days
329
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Basic Information
- Device Name
- ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT
- K Number
- K073309
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Horiba Abx
- Date Received
- November 23, 2007
- Decision Date
- October 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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