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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 K854936
Device Name EIA PROCESSOR
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Applicant Contact MATT KLAMRZYNSKI
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact MATT KLAMRZYNSKI
Regulation Number862.2160
Classification Product Code
JJE  
Date Received12/10/1985
Decision Date 02/06/1986
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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