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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Panels, Test, Susceptibility, Antimicrobial
510(k) Number K020626
Device Name MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN
Applicant
DADE MICROSCAN, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Applicant Contact CYNTHIA VAN DUKER
Correspondent
DADE MICROSCAN, INC.
1584 ENTERPRISE BLVD.
WEST SACRAMENTO,  CA  95691
Correspondent Contact CYNTHIA VAN DUKER
Regulation Number866.1640
Classification Product Code
LTT  
Date Received02/26/2002
Decision Date 04/26/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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