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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 K930185
Device Name OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP
Applicant
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543
Applicant Contact JEMO KANG
Correspondent
Princeton Biomedix
P.O. Box 7139
Princeton,  NJ  08543
Correspondent Contact JEMO KANG
Regulation Number862.1485
Classification Product Code
CEP  
Date Received01/14/1993
Decision Date 03/04/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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