Abbott Spectrum(R) Bicarbonate Reagent
by Abbott Laboratories 510(k)
Active
510(k) K884821
Overview
The ABBOTT SPECTRUM(R) BICARBONATE REAGENT is a clinical chemistry device intended to measure bicarbonate and carbon dioxide levels in plasma, serum, and whole blood samples. It is part of an enzymatic test system designed for accurate and reliable analysis in diagnostic laboratories.
The reagent is supplied as a single-use item and is not reusable. It is intended for use in conjunction with compatible Abbott Spectrum analyzers. The device is not sterilized and should be stored according to the manufacturer's instructions. It is regulated under FDA 510(k) clearance (K884821) and classified as a Class II medical device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884821 | Date27 Dec 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KHS
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1160
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the ABBOTT SPECTRUM(R) BICARBONATE REAGENT used for?
This clinical chemistry device is intended to measure bicarbonate and carbon dioxide levels in plasma, serum, and whole blood samples. It is part of an enzymatic test system designed for accurate and reliable analysis in diagnostic laboratories.
How is the reagent supplied and is it reusable?
The reagent is supplied as a single-use item and is not reusable. It is intended for use in conjunction with compatible Abbott Spectrum analyzers.
Is the reagent sterilized, and how should it be stored?
The device is not sterilized. It should be stored according to the manufacturer's instructions.
What is the regulatory status of this device?
The ABBOTT SPECTRUM(R) BICARBONATE REAGENT is regulated under FDA 510(k) clearance (K884821) and is classified as a Class II medical device.