GSP NEONATAL THYROXINE (T4)


Device Classification Name

enzyme immunoassay, non-radiolabeled, total thyroxine

510(k) Number K103484
Device Name GSP NEONATAL THYROXINE (T4)
Applicant
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
940 winter street
waltham, 
MA 
02451

Applicant Contact susan k hamann
Correspondent
WALLAC OY, A SUBSIDIARY OF PERKINELMER, INC.
940 winter street
waltham, 
MA 
02451

Correspodent Contact susan k hamann
Regulation Number 862.1700
Classification Product Code
KLI  
Date Received 11/26/2010
Decision Date 04/22/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No