PTS PANELS LIPID PANEL TEST STRIPS


Device Classification Name

enzymatic esterase–oxidase, cholesterol

510(k) Number K022898
Device Name PTS PANELS LIPID PANEL TEST STRIPS
Original Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 zionsville rd.
indianapolis, 
IN 
46268

Original Contact margo enright
Regulation Number 862.1175
Classification Product Code
CHH  
Subsequent Product Codes
JGY   LBR  
Date Received 09/03/2002
Decision Date 09/24/2002
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

Recalls CDRH Recalls