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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 K911153
Device Name MICROZYME PHENCYCLIDINE ENZYME IMMUNOASSAY TEST KT
Applicant
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Applicant Contact FRANCIS E CAPITANIO
Correspondent
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Correspondent Contact FRANCIS E CAPITANIO
Classification Product Code
LCM  
Date Received03/15/1991
Decision Date 06/18/1991
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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