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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Manual Antimicrobial Susceptibility Test Systems
510(k) Number K862140
Device Name MICRODILUTION PANELS
Applicant
AMERICAN MICRO SCAN
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Applicant Contact LORRAINE WEAVER
Correspondent
AMERICAN MICRO SCAN
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Correspondent Contact LORRAINE WEAVER
Regulation Number866.1640
Classification Product Code
JWY  
Date Received06/04/1986
Decision Date 07/16/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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