MIC ANTIBIOTIC TEST PANELS

FDA Premarket Approval N50494

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 ANTIBIOTIC TEST PANELS
Generic NamePanels, Test, Susceptibility, Antimicrobial
ApplicantPASCO LABORATORIES, INC.
Date Received1977-05-01
Decision Date1980-04-25
PMAN50494
SupplementS
Product CodeLTT 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address PASCO LABORATORIES, INC. 12750 West 42nd Ave. wheat Ridge, CO 80033

Supplemental Filings

Supplement NumberDateSupplement Type
N50494Original Filing
S011 1983-04-05
S010 1983-04-04
S009 1982-11-03
S008 1982-10-18
S007 1982-07-26
S006 1982-05-04
S005 1982-02-16
S004 1981-12-07
S003 1980-10-24
S002
S001

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