CFR
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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.
Code of Federal Regulations
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