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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 K850480
Device Name OVU STICK SELF-TEST -MODIFICATION
Applicant
MONOCLONAL ANTIBODIES, INC.
2319 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MICHAEL C MALONEY
Correspondent
MONOCLONAL ANTIBODIES, INC.
2319 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MICHAEL C MALONEY
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/30/1985
Decision Date 03/05/1985
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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