WAKO L-TYPE GLUCOSE 2


Device Classification Name

hexokinase, glucose

510(k) Number K024281
Device Name WAKO L-TYPE GLUCOSE 2
Original Applicant
WAKO CHEMICALS, USA, INC.
1600 bellwood road
richmond, 
VA 
23237

Original Contact tonya mallory
Regulation Number 862.1345
Classification Product Code
CFR  
Date Received 12/23/2002
Decision Date 02/24/2003
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