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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent/Device, Inoculum Calibration
510(k) Number K935566
Device Name SENSI-CAL AMCO AEPA-1
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
LIE  
Date Received11/18/1993
Decision Date 03/29/1994
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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