21 CFR § 864.3400 - Device for sealing microsections.
(a) Identification. A device for sealing microsections is an automated instrument used to seal stained cells and microsections for histological and cytological examination.
(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.
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