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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 K851332
Device Name BLHI LUTEINIZING HORMONE
Applicant
EURO-DIAGNOSTICS BV
R.W. GREEFF & CO.
1445 EAST PUTNAM AVENUE
OLD GREENWICH,  CT  06870
Applicant Contact PAUL M SZUTOWICZ
Correspondent
EURO-DIAGNOSTICS BV
R.W. GREEFF & CO.
1445 EAST PUTNAM AVENUE
OLD GREENWICH,  CT  06870
Correspondent Contact PAUL M SZUTOWICZ
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/04/1985
Decision Date 07/09/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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