PICCOLO HDL TEST SYSTEM


Device Classification Name

ldl & vldl precipitation, cholesterol via esterase-oxidase, hdl

510(k) Number K023640
Device Name PICCOLO HDL TEST SYSTEM
Original Applicant
ABAXIS, INC.
3240 whipple rd.
union city, 
CA 
94587

Original Contact dennis m bleile
Regulation Number 862.1475
Classification Product Code
LBS  
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

Yes