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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode, Ion Specific, Potassium
510(k) Number K974784
Device Name AVL OPTI CRITICAL CARE ANALYZER
Applicant
Avl Scientific Corp.
33 Mansell Ct.
Roswell,  GA  30076
Applicant Contact RANDY BYRD
Correspondent
Avl Scientific Corp.
235 Hembree Park Dr.
Roswell,  GA  30076
Correspondent Contact Mike Carrasquillo
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CHL   GKR   GLY   JGS  
Date Received12/22/1997
Decision Date 02/24/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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