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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gram Negative Identification Panel
510(k) Number K890057
Device Name SENSITITRE AUTO ID PLATE AP80
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Applicant Contact L VEDAA
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Correspondent Contact L VEDAA
Regulation Number866.2660
Classification Product Code
LQM  
Date Received01/06/1989
Decision Date 06/09/1989
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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