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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatography(Gas), Clinical Use
510(k) Number K801745
Device Name VISTA 44 GAS CHROMATOGRAPHY ANALYSIS
Applicant
Varian Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Varian Assoc., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2250
Classification Product Code
KZQ  
Date Received07/28/1980
Decision Date 08/20/1980
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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