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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 K870657
Device Name AVL MODEL 985 ELECTROLYTE ANALYZER
Applicant
AVL SCIENTIFIC CORP.
33 MANSELL COURT
ROSWELL,  GA  30076 -4807
Applicant Contact RANDY BYRD
Correspondent
AVL SCIENTIFIC CORP.
33 MANSELL COURT
ROSWELL,  GA  30076 -4807
Correspondent Contact RANDY BYRD
Regulation Number862.1600
Classification Product Code
CEM  
Date Received02/18/1987
Decision Date 05/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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