AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..


Device Classification Name

fluorometer, for clinical use

510(k) Number K112161
Device Name AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
Applicant
RADIOMETER MEDICAL APS
aakandevej 21
bronshoj, 

DK

dk-2700

Applicant Contact jana s hellmann
Correspondent
RADIOMETER MEDICAL APS
aakandevej 21
bronshoj, 

DK

dk-2700

Correspodent Contact jana s hellmann
Regulation Number 862.2560
Classification Product Code
KHO  
Subsequent Product Codes
DDR   JIT   JJY  
Date Received 07/27/2011
Decision Date 01/20/2012
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