BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30


Device Classification Name

diazo colorimetry, bilirubin

510(k) Number K023330
Device Name BILIRUBIN-SL (TOTAL) ASSAY, MODEL 284-10/30
Original Applicant
DIAGNOSTIC CHEMICALS LTD.
16 mccarville st.
charlottetown, 

CA

c1e 2a6

Original Contact nancy olscamp
Regulation Number 862.1110
Classification Product Code
CIG  
Date Received 10/04/2002
Decision Date 12/11/2002
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