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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K904503
Device Name SERACON CR REFERENCE
Applicant
Bhp Diagnostix, Inc.
237 Lacey St.
Box 37
West Chester,  PA  19381
Applicant Contact LOUISE O'KEEFE
Correspondent
Bhp Diagnostix, Inc.
237 Lacey St.
Box 37
West Chester,  PA  19381
Correspondent Contact LOUISE O'KEEFE
Regulation Number862.1660
Classification Product Code
JJX  
Date Received10/02/1990
Decision Date 11/02/1990
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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