FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
K Number: K130080
·
Decision May 13, 2014
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
39
Applicant Total
7
Review Days
484
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Basic Information
- Device Name
- EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL
- K Number
- K130080
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1215
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medica Corporation
- Date Received
- January 14, 2013
- Decision Date
- May 13, 2014
- Product Code
- JHY
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JHY | Colorimetric Method, Cpk Or Isoenzymes | FDA class 2 | Clinical Chemistry |
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