Biotrol Bilirubin Monoreactif
by Biotrol, USA, Inc. 510(k)
Active
510(k) K884480
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884480 | Date29 Nov 1988 | 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- Withdrawn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, 21 Sep 2026
Biotrol Bilirubin Monoreactif is a clinical chemistry device used for the measurement of bilirubin. It is categorized under product code CIC and is regulated as a Class 2 device.
This device has received FDA 510(k) clearance under the reference number K884480. It is manufactured by Biotrol, USA, Inc.
Other devices from Biotrol, USA, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the intended use of the Biotrol Bilirubin Monoreactif?
The Biotrol Bilirubin Monoreactif is a clinical chemistry device specifically designed for the measurement of bilirubin levels in a laboratory setting.
What is the regulatory status of this device?
The device is classified as a Class 2 medical device and has received FDA 510(k) clearance under the reference number K884480, confirming it is substantially equivalent to predicate devices.
Who is the manufacturer of this bilirubin measurement device?
The Biotrol Bilirubin Monoreactif is manufactured by Biotrol, USA, Inc., located in Westchester, Pennsylvania.