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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, Sodium
510(k) Number K844587
Device Name AVL MODEL 982 ELECTROLYTE ANALYZER
Applicant
Avl Scientific Corp.
33 Mansell Ct.
Roswell,  GA  30076
Applicant Contact RANDY BYRD
Correspondent
Avl Scientific Corp.
33 Mansell Ct.
Roswell,  GA  30076
Correspondent Contact RANDY BYRD
Regulation Number862.1665
Classification Product Code
JGS  
Date Received11/23/1984
Decision Date 01/18/1985
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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