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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 K921704
Device Name IMMULITE(R) FSH
Applicant
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Applicant Contact DI TULLIO
Correspondent
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Correspondent Contact DI TULLIO
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received04/10/1992
Decision Date 06/09/1992
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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