Tdx(R) Amylase Ii
by Abbott Laboratories 510(k)
Active
510(k) K863622
Overview
The TDX AMYLASE II is a device used for catalytic methods to measure amylase levels in clinical chemistry testing. It is designed for use in laboratory settings to quantify amylase activity in patient samples.
The device is supplied as a Class II medical device with special controls, cleared by the FDA under 510(k) number K863622 on October 3, 1986. It is manufactured by Abbott Laboratories and is intended for single-use in clinical chemistry laboratories. The device is regulated under 862.1070 and is not indicated for MRI safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK863622 | Date3 Oct 1986 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JFJ
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1070
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the TDX AMYLASE II used for?
The TDX AMYLASE II is a device designed for catalytic methods to measure amylase levels in clinical chemistry testing. It is intended for use in laboratory settings to quantify amylase activity in patient samples.
Is the TDX AMYLASE II a single-use device?
Yes, the TDX AMYLASE II is intended for single-use in clinical chemistry laboratories. It is not designed for reuse and should be discarded after one use to ensure accurate test results and maintain safety standards.
What is the regulatory status of the TDX AMYLASE II?
The TDX AMYLASE II is a Class II medical device with special controls, cleared by the FDA under 510(k) number K863622 on October 3, 1986. It is regulated under 862.1070 and is not indicated for MRI safety.
Who manufactures the TDX AMYLASE II?
The TDX AMYLASE II is manufactured by Abbott Laboratories, a company headquartered at One Abbott Park Rd., Abbott Park, IL 60064. The device is part of their clinical chemistry testing product line.