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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 K841545
Device Name ENZYME IMMUNOASSAY FOR DETECTION HORM
Applicant
BTC DIAGNOSTICS, INC.
61 MOULTON STREET
CAMBRIDGE,  MA  02138 -
Applicant Contact WALTER D CANTAROW
Correspondent
BTC DIAGNOSTICS, INC.
61 MOULTON STREET
CAMBRIDGE,  MA  02138 -
Correspondent Contact WALTER D CANTAROW
Regulation Number862.1485
Classification Product Code
CEP  
Date Received04/16/1984
Decision Date 11/27/1984
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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