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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 K945566
Device Name ABBOTT PROJECT I, SPECTRUM
Applicant
ABBOTT LABORATORIES
P.O. BOX 152020
1921 HURD DRIVE
IRVING,  TX  75015 -2020
Applicant Contact Irene Powers
Correspondent
ABBOTT LABORATORIES
P.O. BOX 152020
1921 HURD DRIVE
IRVING,  TX  75015 -2020
Correspondent Contact Irene Powers
Regulation Number862.2160
Classification Product Code
JJE  
Date Received10/21/1994
Decision Date 06/09/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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