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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K843423
Device Name PHYSIO GAS ANALYZER
Applicant
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Applicant Contact MICHAEL N KELLY
Correspondent
Research Medical, Inc.
1847 W. 2300 S.
Salt Lake City,  UT  84119
Correspondent Contact MICHAEL N KELLY
Regulation Number866.5100
Classification Product Code
LLL  
Date Received08/31/1984
Decision Date 02/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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