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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 K915179
Device Name PHENCYCLIDINE EIA ASSAY
Applicant
Diagnostic Reagents, Inc.
3255-4 Scott Blvd.
Suite 102
Santa Clara,  CA  95054
Applicant Contact YUH-GENG TSAY
Correspondent
Diagnostic Reagents, Inc.
3255-4 Scott Blvd.
Suite 102
Santa Clara,  CA  95054
Correspondent Contact YUH-GENG TSAY
Classification Product Code
LCM  
Date Received11/15/1991
Decision Date 12/09/1991
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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