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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alcohol Control Materials
510(k) Number K934467
Device Name BECKMAN CX AMMONIA/ALCOHOL CONTROL
Applicant
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd.
Brea,  CA  92621
Correspondent Contact WILLIAM T RYAN
Regulation Number862.3280
Classification Product Code
DKC  
Date Received09/10/1993
Decision Date 10/27/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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