MIC ANTIBIOTIC TEST PANELS

FDA Premarket Approval N50494 S004

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

DeviceMIC ANTIBIOTIC TEST PANELS
Generic NamePanels, Test, Susceptibility, Antimicrobial
ApplicantPASCO LABORATORIES, INC.
Date Received1981-12-07
Decision Date1982-03-12
PMAN50494
SupplementS004
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.