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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Occult Blood Analyzer
510(k) Number K041408
Device Name POLYMEDCO OC AUTO MICRO 80 FOB TEST
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 Number864.6550
Classification Product Code
OOX  
Date Received05/27/2004
Decision Date 10/21/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
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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