Vista B12 Assay
by Syva Co. 510(k)
Active
510(k) K941235
Overview
The Vista B12 Assay is a radioassay device used for measuring vitamin B12 levels in clinical chemistry testing. It is designed to provide accurate quantification of vitamin B12 in patient samples for diagnostic purposes.
This device is supplied as a single-use assay and is regulated under FDA 510(k) clearance with device class 2. It is manufactured by Syva Co. and is intended for use in clinical chemistry laboratories for vitamin B12 testing.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK941235 | Date15 Aug 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CDD
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1810
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Syva Co.
Questions
What is the Vista B12 Assay used for?
The Vista B12 Assay is used to measure vitamin B12 levels in patient samples for diagnostic purposes in clinical chemistry testing, providing accurate quantification to support clinical decision-making.
Is the Vista B12 Assay single-use or reusable?
The Vista B12 Assay is supplied as a single-use device, meaning it is intended for one-time use only and should not be reprocessed or reused to ensure test accuracy and patient safety.
Who manufactures the Vista B12 Assay and where are they located?
The Vista B12 Assay is manufactured by Syva Co., located at 3403 Yerba Buena Rd., San Jose, CA 95161, United States, as indicated in the device’s registration and mailing address details.