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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact HELEN LANDICHO
Regulation Number862.1035
Classification Product Code
CIX  
Subsequent Product Codes
CDQ   CGX   CIC   KHS  
Date Received03/24/2011
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
Predetermined Change
Control Plan Authorized		 No
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