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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Antigen, Antiserum, Control
510(k) Number K853469
Device Name GILFORD IMMUNOGLOBULIN M REAGENT
Applicant
Gilford
132 Artino St.
Oberlin,  OH  44974
Applicant Contact CRAIG H REASON
Correspondent
Gilford
132 Artino St.
Oberlin,  OH  44974
Correspondent Contact CRAIG H REASON
Regulation Number866.5550
Classification Product Code
DFT  
Date Received08/19/1985
Decision Date 09/16/1985
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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