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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 K780388
Device Name ANALYZER, 100, BICHROMATIC, ABBOTT
Applicant
SYVA CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SYVA CO.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2160
Classification Product Code
JJE  
Date Received03/10/1978
Decision Date 03/22/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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