ATAC 4300 Hematology Cell Counter
by Turpen Laboratory Systems, Inc. 510(k)
Active
510(k) K863332
Overview
The ATAC 4300 Hematology Cell Counter is an automated cell counter used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood. It may also measure additional hematological parameters as part of its function as a particle counter in hematology analysis.
This device received FDA 510(k) clearance (K863332) on September 29, 1986, and is classified as a Class II medical device under regulation number 864.5200 with product code GKL. It is manufactured by Turpen Laboratory Systems, Inc. and is intended for use in clinical laboratory settings for hematology testing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863332 | Date29 Sep 1986 | 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- Withdrawn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 Turpen Laboratory Systems, Inc.
Questions
What is the ATAC 4300 Hematology Cell Counter used for?
The ATAC 4300 is an automated cell counter designed to count red blood cells, white blood cells, and blood platelets using a patient's peripheral blood sample. It functions as a particle counter in hematology analysis, measuring additional hematological parameters in clinical laboratory settings.
Is the ATAC 4300 a single-use or reusable device?
The device data does not specify whether the ATAC 4300 is single-use or reusable. For information about the intended usage pattern, please consult the manufacturer's documentation or contact Turpen Laboratory Systems, Inc. directly.
What regulatory approvals does the ATAC 4300 Hematology Cell Counter have?
The ATAC 4300 received FDA 510(k) clearance (K863332) on September 29, 1986. It is classified as a Class II medical device under regulation number 864.5200 with product code GKL. The device is manufactured by Turpen Laboratory Systems, Inc.
What sizes or models of the ATAC 4300 are available?
The device data does not specify different sizes or models of the ATAC 4300 Hematology Cell Counter. For information about available configurations, please contact the manufacturer directly or refer to their product documentation.
How should the ATAC 4300 Hematology Cell Counter be stored?
The device data does not provide specific storage instructions for the ATAC 4300 Hematology Cell Counter. Proper storage requirements would be detailed in the manufacturer's user manual. For specific guidance, please consult Turpen Laboratory Systems, Inc. documentation.