BIOSCANNER TRIGLYCERIDES TEST STRIPS


the company

Device Classification Name

colorimetric method, triglycerides

510(k) Number K000586
Device Name BIOSCANNER TRIGLYCERIDES TEST STRIPS
Original Applicant
POLYMER TECHNOLOGY SYSTEMS, INC.
7736 zionsville rd.
indianapolis, 
IN 
46268

Original Contact margo enright
Regulation Number 862.1705
Classification Product Code
JGY  
Date Received 02/22/2000
Decision Date 07/03/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No