PARASCRIPT (R) ACCUDETECT (R)
FDA premarket approval P120004/S001 · decided 2015-10-16
Approval details
- PMA number
- P120004
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- PARASCRIPT (R) ACCUDETECT (R)
- Generic name
- Analyzer, medical image
- Applicant
- Parascript, LLC
- Date received
- 2015-01-27
- Decision date
- 2015-10-16
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- MYN
- Advisory committee
- Radiology
- Expedited review
- No
- Location
- Longmont, CO
- Statement
- APPROVAL FOR PARASCRIPT ACCUDETECT VERSION 7.0.
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