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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K934068
Device Name BECKMAN DIRECT BILIRUBIN REAGENT
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 Number862.1110
Classification Product Code
CIG  
Subsequent Product Code
JIS  
Date Received08/20/1993
Decision Date 04/26/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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