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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K954546
Device Name BLOOD GAS MIXTURE
Applicant
Liquid Technology Corp.
6325 N. Orange Blossom
Trail, #118
Orlando,  FL  32810
Applicant Contact DAVE KAGRISE
Correspondent
Liquid Technology Corp.
6325 N. Orange Blossom
Trail, #118
Orlando,  FL  32810
Correspondent Contact DAVE KAGRISE
Regulation Number862.1150
Classification Product Code
JIS  
Subsequent Product Code
BXK  
Date Received09/29/1995
Decision Date 12/28/1995
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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