SERAQUEST ANTI-THYROID PEROXIDASE (TPO)


Device Classification Name

system, test, thyroid autoantibody

510(k) Number K023593
Device Name SERAQUEST ANTI-THYROID PEROXIDASE (TPO)
Original Applicant
QUEST INTL., INC.
1938 n.e. 148th terr.
north miami, 
FL 
33181

Original Contact robert a cort
Regulation Number 866.5870
Classification Product Code
JZO  
Date Received 10/25/2002
Decision Date 02/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No