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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fluorometer
510(k) Number K962499
Device Name ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER
Applicant
BARTELS, INC.
2005 N.W. SAMMAMISH RD., #107
ISSAQUAH,  WA  98027
Applicant Contact REBECCA D FULLER
Correspondent
BARTELS, INC.
2005 N.W. SAMMAMISH RD., #107
ISSAQUAH,  WA  98027
Correspondent Contact REBECCA D FULLER
Regulation Number866.4520
Classification Product Code
JZT  
Subsequent Product Code
GKZ  
Date Received06/26/1996
Decision Date 09/05/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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