AUTODELFIA NEONATAL IRT KIT


Device Classification Name

n-benzoyl-l-arginine ethyl ester (u.v.), trypsin

510(k) Number K110274
Device Name AUTODELFIA NEONATAL IRT KIT
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 862.1725
Classification Product Code
JNO  
Date Received 01/31/2011
Decision Date 06/10/2011
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