Enzymune-Test TSH
510(k) K832823
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832823 | Date14 Oct 1983 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JLW
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1690
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Enzymune-Test TSH is a radioimmunoassay for thyroid-stimulating hormone (TSH). It is classified under product code JLW and device name Radioimmunoassay, Thyroid-Stimulating Hormone.
This device received FDA 510(k) clearance (K832823) on October 14, 1983, as a substantially equivalent device under traditional review. It is intended for use in clinical chemistry settings and is regulated as a Class II medical device with special controls.
Other devices from Icl Scientific
Questions
AI-generated answers, 22 Sep 2026
What is the Enzymune-Test TSH used for?
The Enzymune-Test TSH is a radioimmunoassay designed to measure thyroid-stimulating hormone (TSH) levels in patient samples, intended for use in clinical chemistry laboratories to assess thyroid function.
How is the Enzymune-Test TSH supplied and what is its intended use setting?
The device is supplied as a radioimmunoassay kit for in vitro diagnostic use and is intended for use in clinical chemistry settings, where it measures TSH concentrations in serum or plasma samples.
What regulatory pathway was used for the Enzymune-Test TSH and when was it cleared?
The Enzymune-Test TSH received FDA 510(k) clearance under submission K832823 on October 14, 1983, through a traditional review process, and was found substantially equivalent to a legally marketed predicate device.