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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Immunochemical, Thyroglobulin Autoantibody
510(k) Number K941361
Device Name MICROSOMAL EIA TEST KIT
Applicant
Immunoprobe, Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Applicant Contact PATRICIA B SHRADER
Correspondent
Immunoprobe, Inc.
Columbia Square
555 Thirteenth St. NW
Washington,  DC  20004
Correspondent Contact PATRICIA B SHRADER
Regulation Number866.5870
Classification Product Code
JNL  
Date Received03/21/1994
Decision Date 05/11/1994
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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