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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
Applicant Contact ALBERT P MAYO
Correspondent
Pharmacia, Inc.
800 Centennial Ave.
Piscataway,  NJ  08854
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
Predetermined Change
Control Plan Authorized		 No
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