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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Human Chorionic Gonadotropin
510(k) Number K911796
Device Name IMMULITE(TM) HCG
Applicant
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Applicant Contact ROBERT FENNELL
Correspondent
Cirrus Diagnostics, Inc.
P.O. Box 15
Chester,  NJ  07930
Correspondent Contact ROBERT FENNELL
Regulation Number862.1155
Classification Product Code
DHA  
Date Received04/22/1991
Decision Date 06/20/1991
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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