FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇰 Denmark
SAFEPICO
K Number: K043143
·
Decision Apr 22, 2005
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
28
Review Days
158
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Basic Information
- Device Name
- SAFEPICO
- K Number
- K043143
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Radiometer Medical Aps
- Date Received
- November 15, 2004
- Decision Date
- April 22, 2005
- Product Code
- JKA
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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