UTI MIC TEST PANEL

FDA Premarket Approval N50487 S007

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

DeviceUTI MIC TEST PANEL
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantMICROTECH MEDICAL SYSTEMS, INC.
Date Received1980-12-16
Decision Date1981-05-06
PMAN50487
SupplementS007
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

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