FDA 510(k)
FDA class 1
Substantially Equivalent
🇩🇰 Denmark
HIGH METABOLITE QUALICHECK
K Number: K130415
·
Decision Mar 26, 2013
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
66
Applicant Total
25
Review Days
35
Basic Information
- Device Name
- HIGH METABOLITE QUALICHECK
- K Number
- K130415
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RADIOMETER MEDICAL APS
- Date Received
- February 19, 2013
- Decision Date
- March 26, 2013
- Product Code
- JJS
- 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 |
|---|---|---|---|
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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