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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, luteinizing hormone
510(k) Number K920411
Device Name IMMULITE HLH
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 Number862.1485
Classification Product Code
CEP  
Date Received01/31/1992
Decision Date 03/11/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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