Quantidex qPCR BCR-ABL IS Kit— 510(k) DEN160003
UnknownAsuragen, Inc.
FDA 510(k) clearance DEN160003 for Quantidex qPCR BCR-ABL IS Kit, Unknown on 2016-07-22. Applicant: Asuragen, Inc.. Device class: 2.
Clearance details
- Applicant
- Asuragen, Inc.
- Product code
- Code OYX
- Device class
- Class 2
- Regulation
- 21 CFR 866.6060
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Austin, TX, US
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More clearances from Asuragen, Inc.
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