Systemate Calcium (Epos Application) #65409
by Em Diagnostic Systems, Inc. 510(k)
Active
510(k) K905659
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK905659 | Date15 Jan 1991 | 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- Withdrawn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
- CIC
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1145
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
The Systemate Calcium (Epos Application) #65409 is a clinical chemistry device used for calcium testing. It is classified as a Class II device under the FDA's 510(k) clearance program.
This device is intended for use in clinical laboratories and is supplied as a single-use item. It is not sterilized and requires proper storage conditions. The device is regulated under FDA 510(k) clearance K905659.
Other devices from Em Diagnostic Systems, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the Systemate Calcium (Epos Application) #65409 used for?
This device is a clinical chemistry instrument intended for the measurement of calcium levels in clinical laboratories.
Is the Systemate Calcium (Epos Application) #65409 sterile?
No, the device is not sterilized and must be stored under proper conditions.
Is the Systemate Calcium (Epos Application) #65409 a single-use device?
Yes, the device is supplied as a single-use item.
What is the regulatory status of the Systemate Calcium (Epos Application) #65409?
The device is cleared by the FDA under the 510(k) clearance program.