Identifiers
- 510(k) Number
- K923925 FDA 510(k)
- FDA Product Code
- JHI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 862.1155 FDA 510(k)
- Regulation Number
- 862.1155 FDA 510(k)
- Advisory Committee
- Clinical Chemistry FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hcg Stat-Pak is a visual, pregnancy Hcg test. It is designed for the detection of human chorionic gonadotropin.
This device is intended for prescription use. It has received FDA 510(k) clearance.
Frequently asked questions
What is the primary purpose of the HCG Stat-Pak?
The HCG Stat-Pak is a visual diagnostic test specifically designed for the detection of human chorionic gonadotropin, which is a hormone marker used to identify pregnancy.
Is this device available for general public purchase?
No, the HCG Stat-Pak is intended for prescription use only. It is designed for clinical settings where a healthcare provider manages the testing process.
Has this device undergone regulatory review?
Yes, the HCG Stat-Pak has received FDA 510(k) clearance. This indicates that the device has been reviewed and determined to be substantially equivalent to legally marketed predicate devices.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HIV 1/2 STAT PAK® Assay International - Chembio Diagnostics, Inc., HCG STAT-PAK (K923925) — FDA 510 (k) | Innolitics, Chagas STAT PAK® Assay International - Chembio Diagnostics, Inc., Chagas STAT-PAK® Assay - Chembio Diagnostic Systems, Inc. - PDF ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K923925 | Class II | Active |
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Manufacturer
- Manufacturer
- Chembio Diagnostic Systems, Inc.
Sources (1)
- FDA 510(k) K923925 24 fields · synced Sep 25, 2026