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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K941156
Device Name TECHNISON AXON SYSTEM
Applicant
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA JR.
Correspondent
Miles, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA JR.
Regulation Number862.1160
Classification Product Code
KHS  
Date Received03/10/1994
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
Predetermined Change
Control Plan Authorized		 No
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