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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 K884091
Device Name SOURCERER
Applicant
John Caunt Scientific , Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd.
Eynsham, Oxon, England,  GB OX8 1JA
Applicant Contact E. V EVISON
Correspondent
John Caunt Scientific , Ltd.
Oakfield Industrial Estate
Stanton Harcourt Rd.
Eynsham, Oxon, England,  GB OX8 1JA
Correspondent Contact E. V EVISON
Regulation Number862.2320
Classification Product Code
JJJ  
Date Received09/28/1988
Decision Date 02/02/1989
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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