Cassette/Urine Hcg
by Ind Diagnostic, Inc. 510(k)
Active
510(k) K023638
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK023638 | Date3 Jan 2003 | 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- Withdrawn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
- LCX
- 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
The Cassette Urine Hcg is a kit, test, pregnancy, hcg, over the counter device used for the in vitro diagnostic detection of human Chorionic Gonadotropin presence in female urine specimens for the early detection of pregnancy. It is a one step urine hcg pregnancy test in cassette format.
The device is supplied for single-use, over-the-counter use, and is used to obtain visual and qualitative results. It is regulated under the product code LCX and regulation number 862.1155, with an FDA 510K authorization, specifically clearance type Traditional, and decision code SESE, dated 2003-01-03.
Other devices from Ind Diagnostic, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Cassette Urine Hcg test used for?
The Cassette Urine Hcg test is used for the in vitro diagnostic detection of human Chorionic Gonadotropin presence in female urine specimens for the early detection of pregnancy.
Is the Cassette Urine Hcg test supplied for single-use or reuse?
The Cassette Urine Hcg test is supplied for single-use.
What type of results does the Cassette Urine Hcg test provide?
The Cassette Urine Hcg test provides visual and qualitative results.
Is the Cassette Urine Hcg test available over-the-counter?
Yes, the Cassette Urine Hcg test is available for over-the-counter use.