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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 K871726
Device Name OVUQUICK SELF-TEST (OVUQUICK; RAMP LH ASSAY)
Applicant
Monoclonal Antibodies, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact GRIFFIN FITZGERALD
Correspondent
Monoclonal Antibodies, Inc.
2319 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number862.1485
Classification Product Code
CEP  
Date Received05/05/1987
Decision Date 07/27/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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