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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter (Beta, Gamma) For Clinical Use
510(k) Number K894902
Device Name SOURCERER
Applicant
Oakfield Instruments, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd., Eynsham
Oxon Ox8 1ja England,  GB
Applicant Contact JOHN GIDDINGS
Correspondent
Oakfield Instruments, Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd., Eynsham
Oxon Ox8 1ja England,  GB
Correspondent Contact JOHN GIDDINGS
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received08/01/1989
Decision Date 10/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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