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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Urinalysis System
510(k) Number K951877
Device Name AUTOMATED ANALYSIS ASSAY FOR BILIRUBIN IN URINE
Applicant
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Applicant Contact CHARLES A HAY
Correspondent
Chimera Research & Chemical, Inc.
P.O. Box 3363
Seminole,  FL  33775
Correspondent Contact CHARLES A HAY
Regulation Number862.2900
Classification Product Code
KQO  
Subsequent Product Code
JIT  
Date Received04/07/1995
Decision Date 05/14/1996
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
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