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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Infectious Mononucleosis
510(k) Number K932688
Device Name EYE SPOT IM TEST
Applicant
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Applicant Contact CHARLES GILL
Correspondent
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Correspondent Contact CHARLES GILL
Regulation Number866.5640
Classification Product Code
KTN  
Date Received06/03/1993
Decision Date 09/08/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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