FDAnews Device Daily Bulletin

MONOGEN RECEIVES APPROVABLE LETTER FROM THE FDA FOR FOR ITS MONOPREP PAP TEST

Dec. 21, 2005
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Oxbow Equities Corp. announced today that its 46% owned investee company MonoGen, Inc. ("MonoGen") has received an approvable letter from the United States Food and Drug Administration (FDA) related to its MonoPrep Pap Test. The letter specifies that the MonoGen premarket approval application (PMA) is approvable subject to certain conditions being met, including a satisfactory outcome from the inspection of the Company's manufacturing facilities and final agreement on labeling.

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