ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL


Device Classification Name

system, test, blood glucose, over the counter

510(k) Number K024234
Device Name ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL
Original Applicant
BAYER CORP.
1884 miles ave.
p.o. box 70
elkhart, 
IN 
46514 -0070

Original Contact george m tancos
Regulation Number 862.1345
Classification Product Code
NBW  
Subsequent Product Code
JQP  
Date Received 12/23/2002
Decision Date 01/23/2003
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