CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80


information about

Device Classification Name

enzymatic, carbon-dioxide

510(k) Number K002354
Device Name CARBON DIOXIDE-L3K-C ASSAY, MODELS 288-30 AND 288-80
Original Applicant
DIAGNOSTIC CHEMICALS LTD.
16 mccarville st.
charlottetown, 

CA

c1e 2a6

Original Contact karen callbeck
Regulation Number 862.1160
Classification Product Code
KHS  
Date Received 08/02/2000
Decision Date 09/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No