Coulter Counter Model S Plus
by Coulter Electronics, Inc. 510(k)
Active
510(k) K792537
Overview
The Coulter Counter Model S Plus is an automated particle counter designed for hematological analysis. It quantifies and sizes suspended particles, such as blood cells, by measuring electrical impedance changes as particles pass through a small aperture. This device is classified as a Class II medical device under FDA regulations and falls under the category of automated cell counters. Its primary function is to provide precise cell counts and size distribution for diagnostic purposes in clinical hematology.
The Coulter Counter Model S Plus is intended for use in clinical laboratories and healthcare settings. It operates as a reusable instrument, requiring calibration and maintenance per manufacturer guidelines. The device is not sterile and is regulated under 21 CFR 864.5200, with an FDA 510(k) clearance (K792537) granted in 1980. No specific MRI safety information is provided, and its operation depends on electrical components and fluid dynamics. Storage and handling must comply with laboratory protocols to ensure accuracy and reliability.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK792537 | Date29 Jan 1980 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- GKL
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5200
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Coulter Electronics, Inc.
Questions
What is the Coulter Counter Model S Plus used for in clinical settings?
The Coulter Counter Model S Plus is designed for automated hematological analysis, specifically quantifying and measuring the size of suspended particles like blood cells. It achieves this by detecting electrical impedance changes as particles pass through a small aperture, providing precise cell counts and size distribution for diagnostic purposes in clinical laboratories.
Is the Coulter Counter Model S Plus a single-use or reusable device?
The Coulter Counter Model S Plus is a reusable instrument. It requires regular calibration and maintenance as outlined in the manufacturer’s guidelines to ensure accurate and reliable performance over time.
What regulatory approval does the Coulter Counter Model S Plus hold?
The Coulter Counter Model S Plus holds FDA 510(k) clearance under the designation K792537, granted in 1980. It is classified as a Class II medical device under FDA regulations and is regulated under 21 CFR 864.5200.
How should the Coulter Counter Model S Plus be stored and handled?
The Coulter Counter Model S Plus must be stored and handled according to standard laboratory protocols to maintain its accuracy and reliability. Since it is not sterile and relies on electrical components and fluid dynamics, proper environmental conditions and maintenance are critical to prevent contamination or malfunctions.
Are there any specific safety considerations for using the Coulter Counter Model S Plus near MRI equipment?
No specific MRI safety information is provided for the Coulter Counter Model S Plus. Since its operation depends on electrical components and fluid dynamics, users should follow general laboratory safety guidelines and avoid exposing the device to MRI environments unless confirmed safe by the manufacturer.