Title 21

SECTION 864.3400

864.3400 Device for sealing microsections.

§ 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.

[45 FR 60589, Sept. 12, 1980, as amended at 54 FR 25044, June 12, 1989; 66 FR 38789, July 25, 2001]

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