INDIKO


Device Classification Name

analyzer, chemistry (photometric, discrete), for clinical use

510(k) Number K110035
Device Name INDIKO
Applicant
THERMO FISHER SCIENTIFIC OY
ratastie 2
vantaa, 

FI

01620

Applicant Contact paivi sormunen
Correspondent
THERMO FISHER SCIENTIFIC OY
ratastie 2
vantaa, 

FI

01620

Correspodent Contact paivi sormunen
Regulation Number 862.2160
Classification Product Code
JJE  
Subsequent Product Code
CFR  
Date Received 01/05/2011
Decision Date 06/28/2011
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