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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 K903052
Device Name IMMUNOCORP LH IRMA COATED TUBE
Applicant
IMMUNOCORP SCIENCES, INC.
5800 ROYALMOUNT
MONTREAL (QUEBEC),  CA H4P 1K5
Correspondent
IMMUNOCORP SCIENCES, INC.
5800 ROYALMOUNT
MONTREAL (QUEBEC),  CA H4P 1K5
Regulation Number862.1485
Classification Product Code
CEP  
Date Received07/11/1990
Decision Date 08/29/1990
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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