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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K844026
Device Name SERACON TM SR IV
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 Number862.1150
Classification Product Code
JIX  
Date Received10/15/1984
Decision Date 11/27/1984
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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