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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 K983345
Device Name BAYER IMMUNO 1 SYSTEM, UPGRADED FOR A LABORATORY
Applicant
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Applicant Contact GABRIEL J MURACA JR
Correspondent
BAYER CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591 -5097
Correspondent Contact GABRIEL J MURACA JR
Regulation Number862.2160
Classification Product Code
JJE  
Date Received09/23/1998
Decision Date 12/07/1998
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
Predetermined Change
Control Plan Authorized		 No
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