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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controls For Blood-Gases, (Assayed And Unassayed)
510(k) Number K961355
Device Name MULTICHECK
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Correspondent Contact DONALD L BAKER
Regulation Number862.1660
Classification Product Code
JJS  
Date Received04/08/1996
Decision Date 06/14/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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