PICCOLO TOTAL CHOLESTEROL TEST SYSTEM


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K023642
Device Name PICCOLO TOTAL CHOLESTEROL TEST SYSTEM
Original Applicant
ABAXIS, INC.
3240 whipple rd.
union city, 
CA 
94587

Original Contact dennis m bleile
Regulation Number 862.1175
Classification Product Code
CHH  
Date Received 10/30/2002
Decision Date 01/24/2003
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