MODIFICATION TO ALKP


Device Classification Name

nitrophenylphosphate, alkaline phosphatase or isoenzymes

510(k) Number K023807
Device Name MODIFICATION TO ALKP
Original Applicant
ABBOTT LABORATORIES
1920 hurd dr.
irving, 
TX 
75038

Original Contact linda morris
Regulation Number 862.1050
Classification Product Code
CJE  
Date Received 11/14/2002
Decision Date 12/26/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No