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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER H: MEDICAL DEVICES
PART 862: CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
Subpart C: Clinical Laboratory Instruments
862.2050 - General purpose laboratory equipment labeled or promoted for a specific medical use.
(a) Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
(b) Classification. 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.
[52 FR 16122, May 1, 1987, as amended at 66 FR 38788, July 25, 2001]
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