Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2014-N-1251]
Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System AGENCY: Food and Drug Administration, HHS. ACTION: Final order.
SUMMARY: The Food and Drug Administration (FDA) is classifying tryptase test system devices into class II (special controls). The Agency is classifying the device into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of the device.
DATES: This order is effective October 20, 2014. The classification was applicable February 15, 2012.
FOR FURTHER INFORMATION CONTACT: Elizabeth Stafford, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301- 796-6184.