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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrolyte Controls (Assayed And Unassayed)
510(k) Number K863333
Device Name AVL ISE-TROL ELECTROLYTE CONTROL
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 Number862.1660
Classification Product Code
JJR  
Date Received08/28/1986
Decision Date 09/29/1986
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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