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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 K902208
Device Name MODIFIED OVUGEN
Applicant
BIOGENEX LABORATORIES
4600 NORRIS CANYON RD.
SAN RAMON,  CA  94583
Applicant Contact KRISHAN L KALRA,PHD
Correspondent
BIOGENEX LABORATORIES
4600 NORRIS CANYON RD.
SAN RAMON,  CA  94583
Correspondent Contact KRISHAN L KALRA,PHD
Regulation Number862.1485
Classification Product Code
CEP  
Date Received05/16/1990
Decision Date 07/17/1990
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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