Medical Devices; Immunology and Microbiology Devices; Classification of Tryptase Test System
fda-device · Food and Drug Administration · Rule · Published 2014-09-18 · Effective 2014-10-20 · 79 FR 56009
Document
Document number
2014-22254
Federal Register citation
79 FR 56009
CFR reference
21 CFR 866
Type
Rule
Action
Final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2014-09-18
Effective date
2014-10-20
HHS docket
Docket No. FDA-2014-N-1251
Abstract
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.