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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 K883814
Device Name DELFIA HLH SPEC KIT
Applicant
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Applicant Contact ALBERT P MAYO
Correspondent
PHARMACIA, INC.
800 CENTENNIAL AVE.
PISCATAWAY,  NJ  08854 -3911
Correspondent Contact ALBERT P MAYO
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/08/1988
Decision Date 03/08/1989
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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