Coulter Counter Model M4
by Coulter Electronics, Inc. 510(k)
Active
510(k) K843303
Overview
The Coulter Counter Model M4 is an Automated Cell Counter designed to measure and enumerate blood cells and other particulate matter in suspension. Operating on the Coulter principle, it detects particles by their volume as they pass through an aperture, generating electrical pulses proportional to size. This device is classified under Counter, Cell, Automated (Particle Counter) and is primarily used in hematology for automated blood cell analysis, including red blood cells, white blood cells, and platelets.
The Model M4 is supplied as a reusable laboratory instrument intended for use in clinical or research settings. It requires calibration and maintenance per manufacturer guidelines, with no indication of sterility or single-use requirements. The device is FDA-cleared under 510(k) K843303 and falls under Regulation 864.5200, classified as a Class II medical device. No MRI safety or size-specific storage instructions are provided in the data. Authorized use is limited to the specified hematology applications as defined by the original submission.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843303 | Date5 Dec 1984 | 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- Withdrawn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 M4 used for?
The Coulter Counter Model M4 is an automated cell counter designed specifically for measuring and enumerating blood cells—including red blood cells, white blood cells, and platelets—as well as other particulate matter in suspension. It operates by detecting particle volume as they pass through an aperture, generating electrical pulses proportional to size. This makes it ideal for clinical hematology and research applications requiring accurate, high-throughput cell analysis.
Is the Coulter Counter Model M4 reusable or single-use?
The Coulter Counter Model M4 is supplied as a reusable laboratory instrument. It is intended for repeated use in clinical or research settings, though it requires regular calibration and maintenance as outlined by the manufacturer to ensure accuracy and reliability. There are no indications of single-use requirements or sterility for the device itself.
What regulatory approvals does the Coulter Counter Model M4 hold?
The Coulter Counter Model M4 holds FDA clearance under 510(k) number K843303, classified as a Class II medical device under regulation 864.5200. The device was determined to be substantially equivalent to a predicate product through a traditional 510(k) review process by the Hematology Advisory Committee. This clearance authorizes its use for specified hematology applications as defined in the original submission.
How is the Coulter Counter Model M4 supplied, and what maintenance is required?
The Coulter Counter Model M4 is supplied as a standalone laboratory instrument, not as a disposable or pre-packaged consumable. Since it is reusable, it requires periodic calibration and routine maintenance to sustain performance. The manufacturer provides guidelines for these procedures, which are critical to ensuring accurate cell counting and preventing operational errors.
Are there any special storage instructions for the Coulter Counter Model M4?
The provided documentation does not specify any unique storage requirements such as temperature controls, humidity levels, or MRI safety considerations for the Coulter Counter Model M4. However, standard laboratory practices for electronic equipment—such as protection from dust, moisture, and physical damage—should be followed to maintain functionality. Always refer to the manufacturer’s operational manual for additional best-practice recommendations.