Source: http://www.law.cornell.edu/cfr/text/21/862.2050
Timestamp: 2014-11-29 09:54:41
Document Index: 627396643

Matched Legal Cases: ['art 862', '§ 862', 'art 807', '§ 862', 'art 820', '§ 820', '§ 820']

21 CFR 862.2050 - General purpose laboratory equipment labeled or promoted for a specific medical use. | LII / Legal Information Institute
CFR › Title 21 › Chapter I › Subchapter H › Part 862 › Subpart C › Section 862.2050 21 CFR 862.2050 - General purpose laboratory equipment labeled or promoted for a specific medical use.
§ 862.2050
Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.