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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Fibrin Split Products
510(k) Number K842277
Device Name DIMERTEST LATEX
Applicant
MABCO, INC.
P.O. BOX 475
SPRINGWOOD QLD 4127 AUSTR,  AT
Applicant Contact WATSON
Correspondent
MABCO, INC.
P.O. BOX 475
SPRINGWOOD QLD 4127 AUSTR,  AT
Correspondent Contact WATSON
Regulation Number864.7320
Classification Product Code
GHH  
Date Received06/08/1984
Decision Date 04/03/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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