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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
Classification Namemanual antimicrobial susceptibility test systems
Generic Namemanual antimicrobial susceptibility test systems
Regulation Number866.1640
200 express street
plainview, NY 11803-
PMA NumberP830028
Date Received03/25/1983
Decision Date03/01/1984
Reclassified Date 05/06/2003
Product Code
JWY[ Registered Establishments with JWY ]
Docket Number 84M-0129
Notice Date 04/25/1984
Advisory Committee Microbiology
Expedited Review Granted? No
Combination Product No
Supplements: S001