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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 K951241
Device Name HAEMOPHILUS/PNEUMOCOCCUS MIC PLATE
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Applicant Contact JENNIFER LORBACH
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact JENNIFER LORBACH
Regulation Number866.1640
Classification Product Code
JWY  
Date Received02/27/1995
Decision Date 10/07/1995
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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