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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 K100499
Device Name ORGENTEC RHEUMATOID FACTOR EIA
Applicant
Orgentec Diagnostika GmbH
150 Cherry Ln. Rd.
East Stroudsburg,  PA  18301
Applicant Contact Gary Lehnus
Correspondent
Orgentec Diagnostika GmbH
150 Cherry Ln. Rd.
East Stroudsburg,  PA  18301
Correspondent Contact Gary Lehnus
Regulation Number866.5775
Classification Product Code
DHR  
Date Received02/22/2010
Decision Date 10/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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