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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, Calcium
510(k) Number K972673
Device Name AVL 9181 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 Number862.1145
Classification Product Code
JFP  
Subsequent Product Codes
CEM   CGZ   JGS   JIH  
Date Received07/16/1997
Decision Date 08/20/1997
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
Recalls CDRH Recalls
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