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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Antigen, Antiserum, Control
510(k) Number K945522
Device Name I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS
Applicant
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92821
Applicant Contact DON W HART
Correspondent
Beckman-Diagnostic Systems Group
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92821
Correspondent Contact DON W HART
Regulation Number866.5550
Classification Product Code
DFT  
Subsequent Product Codes
DEH   DFH  
Date Received11/10/1994
Decision Date 12/12/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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