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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Chromatography (Liquid, Gel), Clinical Use
510(k) Number K931227
Device Name USDT FLOW IMMUNOASSAY SYSTEM, MODEL 9000
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
Regulation Number862.2260
Classification Product Code
KZR  
Date Received03/10/1993
Decision Date 05/06/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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