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Electronic Code of Federal Regulations

e-CFR data is current as of February 21, 2020

Title 21Chapter ISubchapter HPart 864Subpart D → §864.3800


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart D—Pathology Instrumentation and Accessories


§864.3800   Automated slide stainer.

(a) Identification. An automated slide stainer is a device used to stain histology, cytology, and hematology slides for diagnosis.

(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.

[45 FR 60591, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]

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