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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Carboxyhemoglobin
510(k) Number K910827
Device Name ABL520 BLOOD GAS SYSTEM
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145
Correspondent Contact DONALD L BAKER
Regulation Number864.7425
Classification Product Code
GHS  
Date Received02/27/1991
Decision Date 07/09/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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