Hycel Ldh-Int Test
by Hycel, Inc. 510(k)
Active
510(k) K782176
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK782176 | Date26 Jan 1979 | 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- Withdrawn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
- CFH
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1440
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 21 Sep 2026
The device is a Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase, Lactate Dehydrogenase test system, used in clinical chemistry for the measurement of lactate dehydrogenase activity. It is a diagnostic reagent system designed for in vitro use.
It is supplied as a test kit for use in clinical laboratory settings. The device is intended for professional use and is regulated under FDA 510(k) clearance as a Class II medical device with product code CFH.
Other devices from Hycel, Inc.
Questions
AI-generated answers, 21 Sep 2026
What is the HYCEL LDH-INT TEST used for?
The HYCEL LDH-INT TEST is used to measure lactate dehydrogenase activity in clinical chemistry settings. It is a diagnostic reagent system designed for in vitro use, enabling laboratories to assess LDH levels as part of patient sample analysis.
How is the HYCEL LDH-INT TEST supplied and who is it intended for?
The device is supplied as a test kit for use in clinical laboratory settings. It is intended for professional use by trained laboratory personnel performing in vitro diagnostic testing.
What regulatory pathway was used for the HYCEL LDH-INT TEST?
The HYCEL LDH-INT TEST received FDA 510(k) clearance through a traditional submission process, demonstrating substantial equivalence to a legally marketed predicate device. It is classified as a Class II medical device under product code CFH.