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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 K935629
Device Name USDT PHENCYCLIDINE (PCP) ASSAY COLUMN CAT. NO. 9000-400
Applicant
U.S. Drug Testing, Inc.
10410 Trademark St.
Rancho Cucamonga,  CA  91730
Applicant Contact CLIFFORD BENNETT
Correspondent
U.S. Drug Testing, Inc.
10410 Trademark St.
Rancho Cucamonga,  CA  91730
Correspondent Contact CLIFFORD BENNETT
Classification Product Code
LCM  
Date Received11/23/1993
Decision Date 04/12/1994
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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