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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 K961458
Device Name AVL 9180 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 Received04/15/1996
Decision Date 06/12/1996
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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