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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Test System, Antineutrophil Cytoplasmic Antibodies (Anca)
510(k) Number K962360
Device Name IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES
Applicant
Scimedx Corp.
400 Ford Rd.
Denvill,  NJ  07834
Applicant Contact Gary Lehnus
Correspondent
Scimedx Corp.
400 Ford Rd.
Denvill,  NJ  07834
Correspondent Contact Gary Lehnus
Regulation Number866.5660
Classification Product Code
MOB  
Date Received06/19/1996
Decision Date 09/30/1996
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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