MIC PANELS

FDA Premarket Approval N62160

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceMIC PANELS
Generic NamePanels, Test, Susceptibility, Antimicrobial
ApplicantAMERICAN MICRO SCAN
Date Received1978-06-07
Decision Date1979-04-04
PMAN62160
SupplementS
Product CodeLTT 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address AMERICAN MICRO SCAN 1580 Dell Ave. campbell, CA 95008

Supplemental Filings

Supplement NumberDateSupplement Type
N62160Original Filing
S013 1984-06-12
S012 1983-11-02
S011 1983-10-27
S010 1983-09-19
S009 1983-05-17
S008 1983-04-07
S007 1982-12-22
S006 1982-06-21
S005 1981-02-23
S004 1980-07-31
S003
S002
S001 1979-12-26

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