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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 -7139
Applicant Contact JEMO KANG
Correspondent
PRINCETON BIOMEDIX
P.O. BOX 7139
PRINCETON,  NJ  08543 -7139
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
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