GKJ · Spinner, Slide, Automated
Hematology · 21 CFR 864.5850 · Class 1
Overview
| Product Code | GKJ |
|---|---|
| Device Name | Spinner, Slide, Automated |
| Regulation | 21 CFR 864.5850 |
| Device Class | Class 1 |
| Review Panel | Hematology |
Identification
An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).
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 (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K854962 | MICRO-MAT SYSTEM | Ulster Scientific, Inc. | Dec 23, 1985 | SESE |
| K854121 | MICRO-MAT SYSTEM | Prevo Micro-Mat System | Oct 31, 1985 | SESE |
| K831558 | E-Z PREP | Coulter Electronics, Inc. | Jun 16, 1983 | SESE |
| K811534 | HEMASPINNER | Geometric Data, Div. Smithkline Corp. | Aug 18, 1981 | SESE |
| K771898 | AUTOMATED SLIDE SPINNER | Dynatech Cryomedical Co. | Oct 18, 1977 | SESE |
| K760007 | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | Geometric Data, Div. Smithkline Corp. | Sep 3, 1976 | SESE |
Top Applicants
- Geometric Data, Div. Smithkline Corp. — 2 clearances
- Coulter Electronics, Inc. — 1 clearance
- Dynatech Cryomedical Co. — 1 clearance
- Prevo Micro-Mat System — 1 clearance
- Ulster Scientific, Inc. — 1 clearance
