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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 (photometric, discrete), for clinical use
510(k) Number K974779
Device Name ABBOTT ALCYON(TM) 300 (WITHOUT ISE MODULE) AND 300I (WITH ISE MODULE) ANALYZER
Applicant
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Applicant Contact ANDREW JOHNSON
Correspondent
ABBOTT LABORATORIES
1920 HURD DR.
IRVING,  TX  75038
Correspondent Contact ANDREW JOHNSON
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
CEM   CGZ   JGS  
Date Received12/22/1997
Decision Date 02/13/1998
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
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