PHASE II GBM IGG ANTIBODY EIA TEST


Device Classification Name

devices, measure, antibodies to glomerular basement membrane (gbm)

510(k) Number K011348
Device Name PHASE II GBM IGG ANTIBODY EIA TEST
Original Applicant
SCIMEDX CORP.
400 ford rd.
denville, 
NJ 
07834

Original Contact gary lehnus
Regulation Number 866.5660
Classification Product Code
MVJ  
Date Received 05/02/2001
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