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FDA 510(k), K103227, ORATECT ORAL FLUID DRUG SCREEN DEVICES
FDA 510(k), K103227, ORATECT ORAL FLUID DRUG SCREEN DEVICES
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510(K) Number: K103227
Device Name: ORATECT ORAL FLUID DRUG SCREEN DEVICES
Manufacturer: BRANAN MEDICAL CORPORATION
Device Classification Name: enzyme immunoassay, cocaine and cocaine metabolites
Regulation Number: 862.3250
Classification Product Code: DIO
Date Received: 11/01/2010
Decision Date: 04/11/2012
Regulation Medical Specialty: Toxicology
Device Name: ORATECT ORAL FLUID DRUG SCREEN DEVICES
Manufacturer: BRANAN MEDICAL CORPORATION
Device Classification Name: enzyme immunoassay, cocaine and cocaine metabolites
Regulation Number: 862.3250
Classification Product Code: DIO
Date Received: 11/01/2010
Decision Date: 04/11/2012
Regulation Medical Specialty: Toxicology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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