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HHS - 21 CFR PART 864

HEMATOLOGY AND PATHOLOGY DEVICES

active, Most Current
Organization: HHS
Publication Date: 1 April 2018
Status: active
Page Count: 29
scope:

(a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution.

(b) The identification of a device in a regulation in this part is not a precise description of every device that is, or will be, subject to the regulation. A manufacturer who submits a premarket notification submission for a device under part 807 may not show merely that the device is accurately described by the section title and identification provisions of a regulation in this part, but shall state why the device is substantially equivalent to other devices, as required by ยง 807.87.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

(d) Guidance documents referenced in this part are available on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/default.htm.

Document History

April 1, 2019
HEMATOLOGY AND PATHOLOGY DEVICES
(a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this...
21 CFR PART 864
April 1, 2018
HEMATOLOGY AND PATHOLOGY DEVICES
(a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this...
April 1, 2017
HEMATOLOGY AND PATHOLOGY DEVICES
(a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this...
April 1, 2016
HEMATOLOGY AND PATHOLOGY DEVICES
(a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this...
April 1, 2015
HEMATOLOGY AND PATHOLOGY DEVICES
(a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this...
April 1, 2014
HEMATOLOGY AND PATHOLOGY DEVICES
(a) This part sets forth the classification of hematology and pathology devices intended for human use that are in commercial distribution. (b) The identification of a device in a regulation in this...

References

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