FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
K Number: K120497
·
Decision May 14, 2012
Classifications
1
FEI Numbers
65
Registration Numbers
65
Same Product Code
248
Applicant Total
47
Review Days
83
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Basic Information
- Device Name
- EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIAL
- K Number
- K120497
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7470
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medica Corp.
- Date Received
- February 21, 2012
- Decision Date
- May 14, 2012
- 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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