Chorio-Quant
by Nuclear Medical Laboratories, Inc.
510(k) K820523
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK820523 | Date15 Mar 1982 | 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- Withdrawn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
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
Chorio-Quant is a visual pregnancy human chorionic gonadotropin (HCG) test device. It is designed to detect the presence of HCG to assist in the determination of pregnancy.
This device is intended for prescription use and is regulated under the clinical chemistry medical specialty. It has received FDA 510(k) clearance under the product code JHI.
Other devices from Nuclear Medical Laboratories, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the primary purpose of the Chorio-Quant device?
The Chorio-Quant is a visual test device designed to detect the presence of human chorionic gonadotropin (HCG) in a sample to assist clinicians in the determination of pregnancy.
Is this device available for over-the-counter use?
No, the Chorio-Quant is specifically intended for prescription use only. It is regulated under the clinical chemistry medical specialty and requires professional oversight.
What is the regulatory status of this device?
The Chorio-Quant has received FDA 510(k) clearance under the product code JHI. It is classified as a class 2 medical device under regulation number 862.1155.