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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 K833376
Device Name RIANEN LUTEINIZING HORMONE RIA KIT
Applicant
NEW ENGLAND NUCLEAR
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
NEW ENGLAND NUCLEAR
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/28/1983
Decision Date 12/20/1983
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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