CC-700 Seven Parameter, Automated Hemaa
by Dysmex 510(k)
Active
510(k) K821238
Overview
The CC-700 Seven Parameter, Automated Hemaa is an automated cell counter device used in hematology. It performs seven-parameter analysis of blood samples to provide comprehensive hematological data.
This device is manufactured by Dysmex and is classified as a Class II medical device under regulation 864.5200. It is intended for laboratory use and received FDA 510(k) clearance on May 28, 1982, with the product code GKL. The device is not specified as single-use or reusable, and no information regarding sterility, MRI safety, or storage conditions is provided in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK821238 | Date28 May 1982 | 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- Withdrawn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
Questions
What is the CC-700 Seven Parameter Automated Hemaa used for?
The CC-700 is an automated cell counter device used in hematology to perform seven-parameter analysis of blood samples, providing comprehensive hematological data for laboratory use.
Is the CC-700 device single-use or reusable?
The device data does not specify whether the CC-700 is designed for single-use or reusable applications. This information would need to be obtained directly from the manufacturer or product documentation.
What regulatory approvals does the CC-700 have?
The CC-700 received FDA 510(k) clearance on May 28, 1982, with product code GKL. It is classified as a Class II medical device under regulation 864.5200 and is intended for laboratory use.
What are the specifications of the CC-700 hematology analyzer?
The CC-700 performs seven-parameter analysis of blood samples to provide comprehensive hematological data. It is manufactured by Dysmex and is classified as a Class II medical device. Specific measurements and technical specifications are not provided in the device data.