PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM


Device Classification Name

nad reduction/nadh oxidation, lactate dehydrogenase

510(k) Number K051108
Device Name PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEM
Applicant
ABAXIS, INC.
3240 whipple rd.
union city, 
CA 
94587

Applicant Contact dennis m bleile
Correspondent
ABAXIS, INC.
3240 whipple rd.
union city, 
CA 
94587

Correspodent Contact dennis m bleile
Regulation Number 862.1440
Classification Product Code
CFJ  
Date Received 05/02/2005
Decision Date 07/08/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No