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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 K935515
Device Name MULTICHECK(TM)
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 Received11/15/1993
Decision Date 04/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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