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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 K864144
Device Name LUTEINIZING HORMONE (LH-IRMA) RIA KIT
Applicant
IMMUCHEM CORP.
P.O. BOX 6227
2015 EAST UNIVERSITY DRIVE
CARSON,  CA  90746
Applicant Contact BURNS, PHD
Correspondent
IMMUCHEM CORP.
P.O. BOX 6227
2015 EAST UNIVERSITY DRIVE
CARSON,  CA  90746
Correspondent Contact BURNS, PHD
Regulation Number862.1485
Classification Product Code
CEP  
Date Received10/22/1986
Decision Date 11/24/1986
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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