MICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Premarket Approval P870049 S032

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 labeling changes to the rapid gram positive procedural manuals for interpretive criteria for penicillin and ampicillin when testing streptococcus species other than streptococcus pneumonia.

DeviceMICROSCAN RAPID GRAM POSITIVE FLUOROGENIC PANELS
Classification NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantDADE INTL., INC.
Date Received2001-11-05
Decision Date2001-11-30
PMAP870049
SupplementS032
Product CodeLON
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
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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