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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 K910198
Device Name CIBA CORNING ACS LH IMMUNOASSAY
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Applicant Contact William J Pignato
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Correspondent Contact William J Pignato
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/16/1991
Decision Date 02/04/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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