Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart D - Pathology Instrumentation and Accessories / § 864.3875 Automated tissue processor.
§ 864.3875 Automated tissue processor.
(a) Identification. An automated tissue processor is an automated system used to process tissue specimens for examination through fixation, dehydration, and infiltration.
(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.