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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Prolactin (Lactogen)
510(k) Number K971921
Device Name PROLACTIN (PRL) HORMONE MICROPLATE ELISA
Applicant
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Applicant Contact DREDERICK R JEROME
Correspondent
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Correspondent Contact DREDERICK R JEROME
Regulation Number862.1625
Classification Product Code
CFT  
Date Received05/23/1997
Decision Date 06/24/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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