RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL

FDA Premarket Approval P000041 S003

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a manufacturing site located at riverain medical group, miamisburg, ohio.

DeviceRAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL
Generic NameAnalyzer, Medical Image
ApplicantRIVERAIN MEDICAL GROUP
Date Received2005-11-18
Decision Date2006-07-27
PMAP000041
SupplementS003
Product CodeMYN 
Advisory CommitteeRadiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonExpress Gmp Supplement
Expedited ReviewNo
Combination Product No
Applicant Address RIVERAIN MEDICAL GROUP 3020 South Tech Blvd. miamisburg, OH 45342-4860

Supplemental Filings

Supplement NumberDateSupplement Type
P000041Original Filing
S011 2012-02-14 Normal 180 Day Track No User Fee
S010 2011-09-02 Normal 180 Day Track
S009 2009-12-10 Normal 180 Day Track
S008
S007
S006 2007-07-26 Normal 180 Day Track No User Fee
S005 2006-07-05 Normal 180 Day Track
S004
S003 2005-11-18 Normal 180 Day Track No User Fee
S002 2003-07-10 Normal 180 Day Track No User Fee
S001 2003-02-13 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
M722XD25114C250640 P000041 000
M722XC25114C250640 P000041 000
M722X25122C250640 P000041 000
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.