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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 K844928
Device Name QUANTICEL HHR TWO HUMAN HEMATOLOGY REFERENCE
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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