POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS


Device Classification Name

bromcresol green dye-binding, albumin

510(k) Number K110818
Device Name POLY-CHEM 90 ALBUMIN, BUN, CALCIUM, CARBON DIOXIDE, CREATININE, AND TOTAL PROTEIN TESTS
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 862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDQ   CGX   CIC   KHS  
Date Received 03/24/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No