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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K924061
Device Name CANCER ANTIGEN CONTROL
Applicant
Polymedco, Inc.
510 Furnace Dock Rd.
Cortlandt Manor,  NY  10567
Applicant Contact FRANK J COVIELLO
Correspondent
Polymedco, Inc.
510 Furnace Dock Rd.
Cortlandt Manor,  NY  10567
Correspondent Contact FRANK J COVIELLO
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/12/1992
Decision Date 02/23/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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