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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 K010289
Device Name SCIMEDX PHASE II MPO IGG ANTIBODY EIA
Applicant
SCIMEDX CORP.
400 ford rd.
denville,  NJ  07834
Applicant Contact gary lehnus
Correspondent
SCIMEDX CORP.
400 ford rd.
denville,  NJ  07834
Correspondent Contact gary lehnus
Regulation Number866.5660
Classification Product Code
MOB  
Date Received01/31/2001
Decision Date 03/07/2001
Decision substantially equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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