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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 K840412
Device Name OVU STICK URINE HLH KIT
Applicant
MONOCLONAL ANTIBODIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
MONOCLONAL ANTIBODIES, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/31/1984
Decision Date 04/13/1984
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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