Synermed Total Protein Reagent Kit
by Synermed, Inc. 510(k)
Active
510(k) K903511
Overview
The Synermed Total Protein Reagent Kit is a Biuret (Colorimetric) device for measuring total protein in clinical chemistry applications. It is classified as a Class II medical device under FDA regulation number 862.1635.
The device received FDA 510(k) clearance (K903511) on September 7, 1990, following a traditional review process. It is manufactured by Synermed, Inc. and is supplied in configurations such as 4 X 250 mL + 2 X 250 mL or 6 X 250 mL, as indicated in the device listings.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK903511 | Date7 Sep 1990 | 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- Withdrawn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
- CEK
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1635
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Synermed, Inc.
Questions
What is the Synermed Total Protein Reagent Kit used for?
The Synermed Total Protein Reagent Kit is used for measuring total protein in clinical chemistry applications using a Biuret (Colorimetric) method, as it is specifically designed for this diagnostic purpose in laboratory settings.
How is the Synermed Total Protein Reagent Kit supplied?
The Synermed Total Protein Reagent Kit is supplied in configurations such as 4 X 250 mL + 2 X 250 mL or 6 X 250 mL, as indicated in the device listings, providing flexibility for different laboratory throughput needs.
Is the Synermed Total Protein Reagent Kit a single-use or reusable device?
The Synermed Total Protein Reagent Kit is intended for single-use in clinical chemistry testing, as it is a reagent kit consumed during the measurement process and not designed for reuse after initial application.