QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA


Device Classification Name

autoantibodies, endomysial(tissue transglutaminase)

510(k) Number K011570
Device Name QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
Original Applicant
INOVA DIAGNOSTICS, INC.
10180 scripps ranch blvd.
san diego, 
CA 
92131 -1234

Original Contact brys c myers
Regulation Number 866.5660
Classification Product Code
MVM  
Date Received 05/21/2001
Decision Date 07/09/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No