Serum HCG Assay
by Monoclonal Antibodies, Inc. 510(k)
Active
510(k) K832562
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK832562 | Date12 Sep 1983 | 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- Withdrawn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
- JHI
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 6 Oct 2026
This device is a visual, pregnancy HCG test for prescription use, classified under Clinical Chemistry. It is a substantially equivalent device cleared via the traditional 510(k) pathway under regulation number 862.1155.
It is supplied by Monoclonal Antibodies, Inc. and has FDA 510(k) clearance (K832562). The device is intended for use in clinical chemistry settings and is not described as sterile, single-use, reusable, MRI safe, or with specific sizes or storage conditions in the provided data.
Other devices from Monoclonal Antibodies, Inc.
Questions
AI-generated answers, 6 Oct 2026
What is the Serum HCG Assay used for?
The Serum HCG Assay is a visual pregnancy HCG test intended for prescription use in clinical chemistry settings to detect human chorionic gonadotropin for pregnancy testing.
How is the Serum HCG Assay supplied and cleared for use?
The device is supplied by Monoclonal Antibodies, Inc. and has FDA 510(k) clearance (K832562) as a substantially equivalent device via the traditional 510(k) pathway under regulation number 862.1155.
Is the Serum HCG Assay described as sterile, single-use, or reusable in the provided data?
The provided data does not describe the Serum HCG Assay as sterile, single-use, or reusable; no such specifications are included in the device information.