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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 K884498
Device Name COTUBE LH IRMA ASSAY
Applicant
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547 -1803
Applicant Contact FRANK MATARRESE
Correspondent
BIO-RAD
4000 ALFRED NOBEL DR.
HERCULES,  CA  94547 -1803
Correspondent Contact FRANK MATARRESE
Regulation Number862.1485
Classification Product Code
CEP  
Date Received10/26/1988
Decision Date 12/22/1988
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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