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PARASCRIPT (R) ACCUDETECT (R)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
PARASCRIPT, LLC
Trade Name
PARASCRIPT ACCUDETECT 6.1.0
Generic Name
Analyzer, medical image
Decision Date
8/22/2013
Days to Decision
510 days
Decision Code
APRL
FDA Decision
Reclassification after approval

PARASCRIPT (R) ACCUDETECT (R)

Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
PARASCRIPT, LLC
Trade Name
PARASCRIPT ACCUDETECT 6.1.0
Generic Name
Analyzer, medical image
Decision Date
8/22/2013
Days to Decision
510 days
Decision Code
APRL
FDA Decision
Reclassification after approval