RNARETAIN
FDA 510(k) clearance K113420 · decided 2012-03-16
Clearance details
- K-number
- K113420
- Device name
- RNARETAIN
- Applicant
- Asuragen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-18
- Decision date
- 2012-03-16
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- OZF
- Device class
- 2
- Regulation number
- 866.4070
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.