AUTOBAC MIC TEST SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Premarket Approval N50524 S016

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

DeviceAUTOBAC MIC TEST SYSTEM
Classification NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantORGANON TEKNIKA CORP.
Date Received1983-11-30
Decision Date1985-11-27
PMAN50524
SupplementS016
Product CodeLON
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address ORGANON TEKNIKA CORP. 100 Akzo Ave. durham, NC 27712

Supplemental Filings

Supplement NumberDateSupplement Type
N50524Original Filing
S035 1989-10-04 Normal 180 Day Track
S034
S033 1989-07-24 Normal 180 Day Track
S032 1989-04-05 Normal 180 Day Track
S031 1988-10-25 Normal 180 Day Track
S030 1988-09-01 Normal 180 Day Track
S029 1988-08-09 Normal 180 Day Track
S028 1988-07-01 Normal 180 Day Track
S027 1988-06-23 Special (immediate Track)
S026 1988-05-11 Normal 180 Day Track
S025 1988-03-21 Normal 180 Day Track
S024 1988-02-09 Normal 180 Day Track
S023 1988-01-25 Normal 180 Day Track
S022 1988-01-11 Normal 180 Day Track
S021 1987-11-03 Normal 180 Day Track
S020 1985-10-15
S019 1984-03-28
S018 1984-01-05
S017
S016 1983-11-30
S015
S014 1983-09-13
S013 1983-07-12
S012 1983-02-15
S011 1982-03-12
S010 1982-01-12
S009 1981-12-01
S008 1980-11-10
S007 1980-09-29
S006 1980-03-17
S005 1980-03-17
S004 1980-01-14
S003 1980-01-14
S002 1979-06-21
S001 1979-09-10

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