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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 K854958
Device Name HCG RIA TEST SYSTEM
Applicant
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Applicant Contact MICHAEL R FALVO
Correspondent
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Correspondent Contact MICHAEL R FALVO
Regulation Number862.1155
Classification Product Code
JHI  
Date Received12/11/1985
Decision Date 01/28/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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