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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
510(k) Number K924248
Device Name ACCUTEX SLE LATEX TEST
Applicant
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Applicant Contact RICHARD DAVIS
Correspondent
J.S. Medical Assoc.
19 Strathmore Rd.
Natick,  MA  01760
Correspondent Contact RICHARD DAVIS
Regulation Number866.5100
Classification Product Code
LJM  
Date Received08/24/1992
Decision Date 11/02/1992
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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