21 CFR 864.3400 — Device For Sealing Microsections

Pathology (PA) · Part 864 Subpart D—Pathology Instrumentation and Accessories · § 864.3400

Identification

A device for sealing microsections is an automated instrument used to seal stained cells and microsections for histological and cytological examination.

Classification Rationale

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.

Product Codes

Product CodeDevice NameClassDevicesAttributes
KIMDevice For Sealing Microsections11
Innolitics

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