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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 K895215
Device Name PASCO MIC/ID GRAM-POSITIVE PANEL
Applicant
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Applicant Contact ROBERT
Correspondent
Difco Laboratories, Inc.
P. O. Box 331058
Detroit,  MI  48232
Correspondent Contact ROBERT
Regulation Number866.1640
Classification Product Code
JWY  
Date Received08/18/1989
Decision Date 01/29/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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