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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Purple Dye-Binding, Albumin
510(k) Number K990978
Device Name ALBUMIN BCG, MODEL AL 103-01
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 Number862.1035
Classification Product Code
CJW  
Date Received03/23/1999
Decision Date 05/25/1999
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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