Cleared Traditional

K002107 - IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA.
(FDA 510(k) Clearance)

K002107 · Scimedx Corp. · Immunology

Aug 2000

Decision

23d

Days

Class 2

Risk

K002107 is an FDA 510(k) clearance for the IFA KIT FOR THE DETECTION OF ENDOMYSIAL IGA ANIBODIES USING PRIMATE UMBILICAL CORD (PUC)-EMA/PUC LGA., a Autoantibodies, Endomysial(tissue Transglutaminase) (Class II — Special Controls, product code MVM), submitted by Scimedx Corp. (Denvill, US). The FDA issued a Cleared decision on August 4, 2000, 23 days after receiving the submission on July 12, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K002107 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 2000
Decision Date	August 04, 2000
Days to Decision	23 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement