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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Phencyclidine
510(k) Number K810601
Device Name EMIT-ST SERUM PHENCYCLIDINE ASSAY
Applicant
Syva Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Syva Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LCM  
Date Received03/06/1981
Decision Date 03/17/1981
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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