Source: http://www.law.cornell.edu/cfr/text/21/862.3050
Timestamp: 2014-12-18 11:37:01
Document Index: 670315025

Matched Legal Cases: ['art 862', '§ 862', 'art 862', '§ 351', '§ 360', '§ 360', '§ 360', '§ 360', '§ 360', '§ 371']

21 CFR 862.3050 - Breath-alcohol test system. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 862 › Subpart D › Section 862.3050 21 CFR 862.3050 - Breath-alcohol test system.
There are 2 Updates appearing in the Federal Register for 21 CFR 862. View below or at eCFR (GPOAccess)
§ 862.3050
Breath-alcohol test system.
A breath-alcohol test system is a device intened to measure alcohol in the human breath. Measurements obtained by this device are used in the diagnosis of alcohol intoxication.
Title 21 published on 2014-04-01The following are only the Rules published in the Federal Register after the published date of Title 21.For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.2014-08-25; vol. 79 # 164 - Monday, August 25, 201479 FR 50549 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System
typeregulations.gov FR Doc.2014-20022 RIN Docket No.FDA-2014-N-1112 DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective September 24, 2014. The classification was applicable May 23, 2013. 21 CFR Part 862 SummaryThe Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
79 FR 50551 - Medical Devices; Technical Amendment
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.United States CodeU.S. Code: Title 21 - FOOD AND DRUGS§ 351 - Adulterated drugs and devices§ 360 - Registration of producers of drugs or devices§ 360c - Classification of devices intended for human use§ 360e - Premarket approval§ 360i - Records and reports on devices§ 360j - General provisions respecting control of devices intended for human use§ 371 - Regulations and hearings
Title 21 published on 2014-04-01The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 862 after this date.2014-08-25; vol. 79 # 164 - Monday, August 25, 201479 FR 50549 - Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of Hemoglobin A1c Test System