POLY-CHEM 90 TOTAL BILIRUBIN


Device Classification Name

diazo colorimetry, bilirubin

510(k) Number K111143
Device Name POLY-CHEM 90 TOTAL BILIRUBIN
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 862.1110
Classification Product Code
CIG  
Date Received 04/22/2011
Decision Date 09/01/2011
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