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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K854611
Device Name RAMP URINE HCG ASSAY
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 Number862.1155
Classification Product Code
JHI  
Date Received11/18/1985
Decision Date 12/30/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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