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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, prolactin (lactogen)
510(k) Number K904714
Device Name CIBA CORNING ACS PROLACTIN IMMUNOASSAY
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Applicant Contact J PIGNATO
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
E. WALPOLE,  MA  02032
Correspondent Contact J PIGNATO
Regulation Number862.1625
Classification Product Code
CFT  
Date Received10/18/1990
Decision Date 11/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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