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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K896864
Device Name FOLLICLE STIMULATING HORMONE-EIA-XT
Applicant
In Vitro Diagnostics, Inc.
Bldg. B Suite 1
Bldg. B Suite 1
Littleton,  CO  80120
Applicant Contact MUSICK, PH.D.
Correspondent
In Vitro Diagnostics, Inc.
Bldg. B Suite 1
Bldg. B Suite 1
Littleton,  CO  80120
Correspondent Contact MUSICK, PH.D.
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received12/06/1989
Decision Date 01/11/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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