GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM


definition

Device Classification Name

antibodies, gliadin

510(k) Number K002189
Device Name GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
Original Applicant
SCIMEDX CORP.
400 ford rd.
denville, 
NJ 
07834

Original Contact gary l ehnus
Regulation Number 866.5750
Classification Product Code
MST  
Date Received 07/19/2000
Decision Date 10/19/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No