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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 K853548
Device Name STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS
Applicant
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Applicant Contact KAREN H DARCY
Correspondent
American Dade
P.O. Box 25101
Santa Ana,  CA  92799
Correspondent Contact KAREN H DARCY
Classification Product Code
LCM  
Date Received08/26/1985
Decision Date 09/18/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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