PICCOLO METLYTE 7 REAGENT DISC


Device Classification Name

atp and creatine kinase (enzymatic), creatine

510(k) Number K992140
Device Name PICCOLO METLYTE 7 REAGENT DISC
Applicant
ABAXIS, INC.
1320 chesapeake terrace
sunnyvale, 
CA 
94089

Applicant Contact lisa mcgrath
Correspondent
ABAXIS, INC.
1320 chesapeake terrace
sunnyvale, 
CA 
94089

Correspodent Contact lisa mcgrath
Regulation Number 862.1210
Classification Product Code
JLB  
Subsequent Product Codes
CEM   KHS  
Date Received 06/24/1999
Decision Date 08/26/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

CLIA Waiver CLIA Waiver Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls