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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay (Two-Site Solid Phase), Ferritin
510(k) Number K881138
Device Name CLINICAL ASSAYS GAMMACOAT [125I] FERRITIN IMMUNO.
Applicant
Baxter Healthcare Corp
600 Memorial Dr.
Cambridge,  MA  02139
Applicant Contact NANCY A HORNBAKER
Correspondent
Baxter Healthcare Corp
600 Memorial Dr.
Cambridge,  MA  02139
Correspondent Contact NANCY A HORNBAKER
Regulation Number866.5340
Classification Product Code
JMG  
Date Received03/16/1988
Decision Date 04/21/1988
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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