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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K863648
Device Name SERACON CT 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 Number862.1660
Classification Product Code
JJY  
Date Received09/18/1986
Decision Date 10/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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