GLUCOSE-SL-C ASSAY, MODEL 257-30


Device Classification Name

hexokinase, glucose

510(k) Number K023739
Device Name GLUCOSE-SL-C ASSAY, MODEL 257-30
Original Applicant
DIAGNOSTIC CHEMICALS LTD.
16 mccarville st.
charlottetown, 

CA

c1e 2a6

Original Contact nancy olscamp
Regulation Number 862.1345
Classification Product Code
CFR  
Date Received 11/07/2002
Decision Date 01/17/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No