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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 SOUTH KRAEMER BLVD.
BREA,  CA  92621 -6209
Applicant Contact WILLIAM T RYAN
Correspondent
BECKMAN-DIAGNOSTIC SYSTEMS GROUP
200 SOUTH KRAEMER BLVD.
BREA,  CA  92621 -6209
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
Recalls CDRH Recalls
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