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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (sequential multiple, continuous flow) clinical use
510(k) Number K945915
Device Name AVL OMNI 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 Number862.2150
Classification Product Code
JJC  
Subsequent Product Codes
CEM   CGC   CHL   GKF   GKR  
JFP   JGS  
Date Received12/02/1994
Decision Date 04/05/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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