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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 K944605
Device Name CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM
Applicant
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92821 -6208
Applicant Contact SHERI HALL
Correspondent
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92821 -6208
Correspondent Contact SHERI HALL
Classification Product Code
LCM  
Date Received09/19/1994
Decision Date 12/07/1994
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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