RAPIDSCREEN RS-2000D
FDA premarket approval P000041/S002 · decided 2003-08-08
Approval details
- PMA number
- P000041
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- RAPIDSCREEN RS-2000D
- Generic name
- Analyzer, medical image
- Applicant
- Riverain Medical Group
- Date received
- 2003-07-10
- Decision date
- 2003-08-08
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Miamisburg, OH
- Statement
- APPROVAL FOR A SECOND DEVICE NAME OF "RAPIDSCREEN DIGITAL" (ABBREVIATED "RS-DIGITAL").
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SOFTVIEW, MODEL 2.01 (K092363) | Riverain Medical Group | 2010-03-18 |