FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
K Number: K032827
·
Decision Dec 8, 2003
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
15
Applicant Total
14
Review Days
89
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Basic Information
- Device Name
- KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501
- K Number
- K032827
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9100
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Tyco Healthcare
- Date Received
- September 10, 2003
- Decision Date
- December 8, 2003
- Product Code
- KSR
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| KSR | Container, Empty, For Collection & Processing Of Blood & Blood Components | FDA class 2 | Hematology |
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