MIC TEST PANELS

FDA Premarket Approval N50487

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 TEST PANELS
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantMICROTECH MEDICAL SYSTEMS, INC.
Date Received1976-12-27
Decision Date1977-05-09
PMAN50487
SupplementS
Product CodeLON 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address MICROTECH MEDICAL SYSTEMS, INC. 13930 River Rd. potomic, MD 20854

Supplemental Filings

Supplement NumberDateSupplement Type
N50487Original Filing
S015 1983-07-13
S014
S013 1982-06-29
S012 1982-05-19
S011 1982-04-22
S010 1981-08-13
S009 1981-03-23
S008 1980-12-16
S007 1980-12-16
S006 1980-12-12
S005 1980-08-04
S004 1980-04-14
S003 1979-10-02
S002
S001 1978-12-27

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.