21 CFR 864.3300 — Cytocentrifuge
Pathology (PA) · Part 864 Subpart D—Pathology Instrumentation and Accessories · § 864.3300
Identification
A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for 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 Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IFB | Cytocentrifuge | 1 | 3 |
