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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 K873534
Device Name OVUGEN SURETEST
Applicant
BIOGENEX LABORATORIES
6549 SIERRA LN.
DUBLIN,  CA  94568
Applicant Contact KALRA, PHD
Correspondent
BIOGENEX LABORATORIES
6549 SIERRA LN.
DUBLIN,  CA  94568
Correspondent Contact KALRA, PHD
Regulation Number862.1485
Classification Product Code
CEP  
Date Received09/01/1987
Decision Date 11/23/1987
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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