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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
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