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This article was originally published in The Gray Sheet
ChemTrak: Will "redraft and resubmit" a 510(k) submission for its quantitative Theophylline test -- used to measure blood levels of the drug in asthma patients for proper dosage titration -- following an FDA request for additional information on the original filing. The Sunnyvale, California firm made the decision after determining it could not make FDA's 30-day response deadline...
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