POLY-CHEM 90 ISE MODULE


Device Classification Name

electrode, ion specific, potassium

510(k) Number K112408
Device Name POLY-CHEM 90 ISE MODULE
Applicant
POLYMEDCO, INC.
510 furnace dock rd.
cortlandt manor, 
NY 
10567

Applicant Contact helen landicho
Correspondent
POLYMEDCO, INC.
510 furnace dock rd.
cortlandt manor, 
NY 
10567

Correspodent Contact helen landicho
Regulation Number 862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CGZ   JGS  
Date Received 08/22/2011
Decision Date 11/04/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No