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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-1 STANDARDIZED ANTIMICROBIC SUSCEPTIBILITY SYS
Classification Namesystem, test, automated, antimicrobial susceptibility, short incubation
Generic Namesystem, test, automated, antimicrobial susceptibility, short incubation
Regulation Number866.1645
Applicant
ANALYTICAL PRODUCTS, INC.
200 express street
plainview, NY 11803-
PMA NumberP800029
Supplement NumberS002
Date Received06/19/1981
Decision Date07/27/1981
Product Code
LON[ Registered Establishments with LON ]
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
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