API 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM

FDA Premarket Approval P800029 S010

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

DeviceAPI 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
Generic NameSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
ApplicantANALYTICAL PRODUCTS, INC.
Date Received1984-04-17
Decision Date1984-05-04
PMAP800029
SupplementS010
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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