URYXXON 200 URINE ANALYZER


Device Classification Name

method, enzymatic, glucose (urinary, non-quantitative)

510(k) Number K051034
Device Name URYXXON 200 URINE ANALYZER
Applicant
MACHEREY-NAGEL GMBH & CO., KG.
7361 calhoun place, suite 500
rockville, 
MD 
20855

Applicant Contact eduardo march
Correspondent
MACHEREY-NAGEL GMBH & CO., KG.
7361 calhoun place, suite 500
rockville, 
MD 
20855

Correspodent Contact eduardo march
Regulation Number 862.1340
Classification Product Code
JIL  
Subsequent Product Codes
CDM   CEN   JIN   JIP   JIR  
JJB   JMA   JMT   KQO   KSL   LJX  
Date Received 04/22/2005
Decision Date 11/22/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No