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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 K803278
Device Name LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT
Applicant
IMMUNO NUCLEAR CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
IMMUNO NUCLEAR CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1485
Classification Product Code
CEP  
Date Received12/29/1980
Decision Date 01/21/1981
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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