FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
Quantidex qPCR BCR-ABL IS Kit
K Number: DEN160003
·
Decision Jul 22, 2016
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
4
Applicant Total
3
Review Days
185
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Basic Information
- Device Name
- Quantidex qPCR BCR-ABL IS Kit
- K Number
- DEN160003
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 866.6060
- Medical Specialty
- Medical Genetics
- Decision
- Unknown
- Applicant
- Asuragen, Inc.
- Date Received
- January 19, 2016
- Decision Date
- July 22, 2016
- Product Code
- OYX
- Advisory Committee
- Medical Genetics
- Review Advisory Committee
- MG
- 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 |
|---|---|---|---|
| OYX | Bcr/Abl1 Monitoring Test | FDA class 2 | Medical Genetics |
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