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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 K101059
Device Name OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR PHENCYCLIDINE
Applicant
Omega Laboratories, Inc.
P.O. Box 506
South Lyon,  MI  48178
Applicant Contact ROBERT J BARD
Correspondent
Omega Laboratories, Inc.
P.O. Box 506
South Lyon,  MI  48178
Correspondent Contact ROBERT J BARD
Classification Product Code
LCM  
Date Received04/15/2010
Decision Date 07/12/2010
Decision Substantially Equivalent (SESE)
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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