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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Rheumatoid Factor
510(k) Number K955086
Device Name TEST, RHEUMATOID FACTOR
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 Number866.5775
Classification Product Code
DHR  
Date Received11/07/1995
Decision Date 12/20/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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