AUTOBAC MIC TEST SYSTEM

System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Premarket Approval N50524 S033

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 Received1989-07-24
Decision Date1990-01-22
PMAN50524
SupplementS033
Product CodeLON
Advisory CommitteeMicrobiology
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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