RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E


codes

Device Classification Name

autoantibodies,skin(desmoglein 1 and desmoglein 3)

510(k) Number K000336
Device Name RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E
Original Applicant
RHIGENE, INC.
455 state st.,
suite 104
des plaines, 
IL 
60068

Original Contact dave kolesar
Regulation Number 866.5660
Classification Product Code
NBO  
Date Received 02/03/2000
Decision Date 06/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No