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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 K953534
Device Name AXSYM PHENCYCLIDINE II
Applicant
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Applicant Contact DOUG KENTZ
Correspondent
Abbott Laboratories
100 Abbott Park Rd.
Abbott Park,  IL  60064 -3500
Correspondent Contact DOUG KENTZ
Classification Product Code
LCM  
Date Received07/27/1995
Decision Date 10/26/1995
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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