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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 K780576
Device Name 125-I LABELED HUMAN LUTEINIZING HORMONE
Applicant
PCL-RIA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PCL-RIA, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/10/1978
Decision Date 05/19/1978
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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