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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K780881
Device Name EMIT CLINICAL PROCESSOR - CP 5000
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 Number862.2100
Classification Product Code
JQP  
Date Received05/30/1978
Decision Date 06/22/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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