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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixture, Hematology Quality Control
510(k) Number K844927
Device Name QUANTICEL HHR + TWO HUMAN HEMATOLOGY W/PLATELETS
Applicant
Bhp Diagnostix, Inc.
237 Lacey St.
Box 37
West Chester,  PA  19381
Applicant Contact LOUISE M O'KEEFE
Correspondent
Bhp Diagnostix, Inc.
237 Lacey St.
Box 37
West Chester,  PA  19381
Correspondent Contact LOUISE M O'KEEFE
Regulation Number864.8625
Classification Product Code
JPK  
Date Received12/19/1984
Decision Date 03/22/1985
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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