IFB · Cytocentrifuge
Pathology · 21 CFR 864.3300 · Class 1
Overview
| Product Code | IFB |
|---|---|
| Device Name | Cytocentrifuge |
| Regulation | 21 CFR 864.3300 |
| Device Class | Class 1 |
| Review Panel | Pathology |
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.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K852117 | CYTO-TEK CENTRIFUGE | Miles Laboratories, Inc. | Jun 10, 1985 | SESE |
| K810848 | CYTOBUCKET MODEL 1024 | Cytochem, Inc. | Apr 23, 1981 | SESE |
| K792032 | LEIF CENTRIFUGAL CYTOLOGY BUCKET | Robert C. Leif, Ph.D. | Nov 30, 1979 | SESE |
Top Applicants
- Cytochem, Inc. — 1 clearance
- Miles Laboratories, Inc. — 1 clearance
- Robert C. Leif, Ph.D. — 1 clearance
