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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Follicle-Stimulating Hormone
510(k) Number K843930
Device Name IRMA IMMUNORADIOMETRIC ASSAY-FSH 125I
Applicant
Euro-Diagnostics BV
R.W. Greeff & Co.
1445 E. Putnam Ave.
Old Greenwich,  CT  06870
Applicant Contact PAUL M SZUTOWICZ
Correspondent
Euro-Diagnostics BV
R.W. Greeff & Co.
1445 E. Putnam Ave.
Old Greenwich,  CT  06870
Correspondent Contact PAUL M SZUTOWICZ
Regulation Number862.1300
Classification Product Code
CGJ  
Date Received10/05/1984
Decision Date 10/30/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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