SENSITITRE

FDA Premarket Approval N50531 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

DeviceSENSITITRE
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantTREK DIAGNOSTIC SYSTEMS, INC.
Date Received1983-10-17
Decision Date1984-03-07
PMAN50531
SupplementS007
Product CodeLON 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address TREK DIAGNOSTIC SYSTEMS, INC. 210 Business Park Dr. sun Prairie, WI 53590

Supplemental Filings

Supplement NumberDateSupplement Type
N50531Original Filing
S007 1983-10-17
S006 1982-10-20
S005 1981-11-02
S004 1981-01-30
S003 1980-05-19
S002
S001

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