FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇳 China
Safety Sliding Blood Collection Set
K Number: K232781
·
Decision Mar 7, 2024
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
15
Review Days
178
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Basic Information
- Device Name
- Safety Sliding Blood Collection Set
- K Number
- K232781
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jiangsu Caina Medical Co.,Ltd
- Date Received
- September 11, 2023
- Decision Date
- March 7, 2024
- Product Code
- JKA
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HO
- 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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