MICROSCAN RAPID FLUOROGENIC PANELS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Premarket Approval P870049 S002

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

DeviceMICROSCAN RAPID FLUOROGENIC PANELS
Classification NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantDADE INTL., INC.
Date Received1989-03-02
Decision Date1989-08-02
PMAP870049
SupplementS002
Product CodeLON
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address DADE INTL., INC. 1584 Enterprise Blvd. west Sacramento,, CA 95691

Supplemental Filings

Supplement NumberDateSupplement Type
P870049Original Filing
S032 2001-11-05 Normal 180 Day Track
S031 2001-10-12 Special (immediate Track)
S030 2000-05-17 Special (immediate Track)
S029 1999-06-10 Special (immediate Track)
S028 1999-01-04 Special (immediate Track)
S027 1998-06-09 Special (immediate Track)
S026
S025 1995-09-28 Normal 180 Day Track
S024 1995-08-01 Normal 180 Day Track
S023 1995-02-22 Normal 180 Day Track
S022 1994-09-30 Special (immediate Track)
S021 1994-09-13 Special (immediate Track)
S020 1993-10-20 Special (immediate Track)
S019
S018 1993-04-21 Normal 180 Day Track
S017
S016 1992-01-08 Normal 180 Day Track
S015 1991-11-29 Normal 180 Day Track
S014 1991-08-22 Normal 180 Day Track
S013 1991-06-28 Normal 180 Day Track
S012 1991-05-21 Normal 180 Day Track
S011 1991-05-17 Normal 180 Day Track
S010 1990-11-21 Normal 180 Day Track
S009 1990-11-07 Normal 180 Day Track
S008 1990-10-25 Normal 180 Day Track
S007
S006
S005 1989-12-26 Normal 180 Day Track
S004 1989-07-20 Normal 180 Day Track
S003 1989-03-20 Normal 180 Day Track
S002 1989-03-02 Normal 180 Day Track
S001 1988-12-13 Normal 180 Day Track

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