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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anti-Dna Antibody, Antigen And Control
510(k) Number K872085
Device Name THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS
Applicant
Immunodiagnostics, Ltd.
District 12, Washington
Tyne & Wear
England, U.K.,  GB NE373HS
Applicant Contact HAYDEN JEFFERY
Correspondent
Immunodiagnostics, Ltd.
District 12, Washington
Tyne & Wear
England, U.K.,  GB NE373HS
Correspondent Contact HAYDEN JEFFERY
Regulation Number866.5100
Classification Product Code
LSW  
Date Received06/01/1987
Decision Date 09/01/1987
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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