PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K023268
Device Name PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS
Original Applicant
PHOENIX DIAGNOSTICS, INC.
8 tech circle
natick, 
MA 
01760

Original Contact ram nunna
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 09/30/2002
Decision Date 11/15/2002
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