API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM

FDA Premarket Approval P800029

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

DeviceAPI 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantANALYTICAL PRODUCTS, INC.
Date Received1980-06-02
Decision Date1981-01-30
Notice Date1981-04-28
PMAP800029
SupplementS
Product CodeLON 
Advisory CommitteeMicrobiology
Expedited ReviewNo
Combination Product No
Applicant Address ANALYTICAL PRODUCTS, INC. 200 Express Street plainview , NY 11803-

Supplemental Filings

Supplement NumberDateSupplement Type
P800029Original Filing
S010 1984-04-17
S009 1984-04-05
S008 1983-08-23
S007 1983-06-28
S006
S005 1982-12-03
S004
S003 1982-05-12
S002 1981-06-19
S001 1981-02-12

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