GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS


Device Classification Name

glucose oxidase, glucose

510(k) Number K033055
Device Name GLUCOSE REAGENT FOR BECKMAN SYNCHRON CX & CX DELTA SYSTEMS
Applicant
DIAMOND DIAGNOSTICS, INC.
331 fiske st.
holliston, 
MA 
01746

Applicant Contact linda stundtner
Correspondent
DIAMOND DIAGNOSTICS, INC.
331 fiske st.
holliston, 
MA 
01746

Correspodent Contact linda stundtner
Regulation Number 862.1345
Classification Product Code
CGA  
Date Received 09/29/2003
Decision Date 01/30/2004
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