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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 K991866
Device Name BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
Applicant
A.P. Total Care, Inc.
70 Hawley Ave.,
P.O. Box 6216
Bridgeport,  CT 
Applicant Contact LUIS P LEON
Correspondent
A.P. Total Care, Inc.
70 Hawley Ave.,
P.O. Box 6216
Bridgeport,  CT 
Correspondent Contact LUIS P LEON
Regulation Number862.1110
Classification Product Code
CIG  
Date Received06/01/1999
Decision Date 08/02/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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