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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 K093989
Device Name ORAL FLUID PHENCYCLIDINE
Applicant
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact MICHELLE LEE NEFF
Correspondent
Roche Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact MICHELLE LEE NEFF
Classification Product Code
LCM  
Subsequent Product Codes
DIF   DKB  
Date Received12/24/2009
Decision Date 01/25/2011
Decision Substantially Equivalent (SESE)
510k Review Panel Clinical Chemistry
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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