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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
510(k) Number K011348
Device Name PHASE II GBM IGG ANTIBODY EIA TEST
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
MVJ  
Date Received05/02/2001
Decision Date 06/25/2001
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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