Hc Plus
by Coulter Electronics, Inc. 510(k)
Active
510(k) K833563
Overview
The Hc Plus is a Mixture, Hematology Quality Control device, classified as a class 2 device. It is used in the field of Hematology. The device has a product code of JPK and a regulation number of 864.8625.
The Hc Plus is supplied by Coulter Electronics, Inc. and has been authorized with an FDA 510K clearance, with the decision description being Substantially Equivalent. The device has a specific k number, K833563, and is associated with various fei numbers and registration numbers.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK833563 | Date3 Jan 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- Withdrawn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
- JPK
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8625
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Coulter Electronics, Inc.
Questions
What is the HC Plus device used for?
The HC Plus is used in the field of Hematology as a quality control device, specifically as a Mixture, Hematology Quality Control device.
What is the regulatory status of the HC Plus device?
The HC Plus has been authorized with an FDA 510K clearance, with the decision description being Substantially Equivalent.
What type of device is the HC Plus classified as?
The HC Plus is classified as a class 2 device, with a product code of JPK and a regulation number of 864.8625.