CMTR-CHEMTRAK FDA OK Message Board

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Biotech / Medical : CMTR-CHEMTRAK FDA OK

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To: Dave O. who wrote (15)	8/30/1996 10:46:00 AM
From: DeadHead	of 1172

No, it was their Theophylline test for asthma patients. SUNNYVALE, Calif., Aug 16 (Reuter) - ChemTrak Inc said it will withdraw and redraft its U.S. Food and Drug Administration filing seeking marketing clearance for its Theophylline test for asthma patients. ChemTrak said it will redraft its 501(k) filing for the test after receiving requests from the FDA for additional data. "We expect to do a small number of in-house studies and reformat the data to provide the additional information requested by the FDA reviewer," said Prithipal Singh, ChemTrak's chairman. "Technically, we are withdrawing the original application to make adjustments."

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