URIC ACID (AOX), SCAL, NORTROL, ABTROL


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K073612
Device Name URIC ACID (AOX), SCAL, NORTROL, ABTROL
Applicant
THERMO FISHER SCIENTIFIC OY
2 ratastie
p.o. box 100
vantaa, 

FI

fin-01621

Applicant Contact paivi sormunen
Correspondent
THERMO FISHER SCIENTIFIC OY
2 ratastie
p.o. box 100
vantaa, 

FI

fin-01621

Correspodent Contact paivi sormunen
Regulation Number 862.1150
Classification Product Code
JIX  
Subsequent Product Codes
JJY   KNK  
Date Received 12/21/2007
Decision Date 05/23/2008
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