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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: 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.
 
DeviceAPI 3600S ANTIMICROBIAL SUSCEPTIBILITY SYSTEM
Generic NameSYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
Regulation Number866.1645
ApplicantAnalytical Products, Inc.
200 Express St.
Plainview, NY 11803
PMA NumberP800029
Supplement NumberS003
Date Received05/12/1982
Decision Date06/18/1982
Reclassified Date05/06/2003
Product Code LON 
Advisory Committee Microbiology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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