CLEAREAD DETECT
FDA premarket approval P000041/S011 · decided 2012-02-27
Approval details
- PMA number
- P000041
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CLEAREAD DETECT
- Generic name
- Analyzer, medical image
- Applicant
- Riverain Medical Group
- Date received
- 2012-02-14
- Decision date
- 2012-02-27
- Days to decision
- 13 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Miamisburg, OH
- Statement
- APPROVAL TO MARKET THE DEVICE UNDER THE ADDITIONAL TRADE NAME CLEARREAD DETECT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SOFTVIEW, MODEL 2.01 (K092363) | Riverain Medical Group | 2010-03-18 |