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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator For Red-Cell And White-Cell Counting
510(k) Number K844708
Device Name TRI-COUNT CALIBRATOR
Applicant
Hematology Marketing Assoc.
P.O. Box 6756
Concord,  CA  94524
Applicant Contact JAMES LAPICOLA
Correspondent
Hematology Marketing Assoc.
P.O. Box 6756
Concord,  CA  94524
Correspondent Contact JAMES LAPICOLA
Regulation Number864.8185
Classification Product Code
KSA  
Date Received12/03/1984
Decision Date 03/05/1985
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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