PTS PANELS MULTI-CHEMISTRY CONTROLS


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K022401
Device Name PTS PANELS MULTI-CHEMISTRY CONTROLS
Original Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 zionsville rd.
indianapolis, 
IN 
46268

Original Contact margo enright
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 07/23/2002
Decision Date 08/21/2002
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