Danam VECTOR-8+
by Danam Electronics 510(k)
Active
510(k) K892205
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892205 | Date13 Jun 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- 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
- GKZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.5220
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The device is a Counter, Differential Cell as defined in the nomenclature authority. It is a hematology instrument used for counting and differentiating cells.
It was cleared through the FDA 510(k) process under number K892205 with a traditional clearance type. The device is classified as class 2, has product code GKZ, and is regulated under regulation number 864.5220 for hematology specialty.
Other devices from Danam Electronics
Questions
AI-generated answers, 1 Oct 2026
What is the DANAM VECTOR-8+ used for?
The DANAM VECTOR-8+ is a hematology instrument designed for counting and differentiating cells, as defined in the nomenclature authority for Counter, Differential Cell devices.
How was the DANAM VECTOR-8+ cleared for market?
The device was cleared through the FDA 510(k) process under submission number K892205 with a traditional clearance type, determined to be substantially equivalent to a predicate device.
What regulatory classification applies to the DANAM VECTOR-8+?
The DANAM VECTOR-8+ is classified as a Class 2 medical device with product code GKZ and is regulated under 21 CFR 864.5220 for hematology specialty devices.