FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
FACTOR V LEIDEN KIT
K Number: DEN030005
·
Decision Dec 17, 2003
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
5
Applicant Total
264
Review Days
9
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Basic Information
- Device Name
- FACTOR V LEIDEN KIT
- K Number
- DEN030005
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 864.7280
- Medical Specialty
- Hematology
- Decision
- Unknown
- Applicant
- Roche Diagnostics Corp.
- Date Received
- December 8, 2003
- Decision Date
- December 17, 2003
- Product Code
- NPQ
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | FDA class 2 | Hematology |
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