Pregnosticon Pregnancy Test Kit
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K790734 FDA 510(k)
- FDA Product Code
- JHJ 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 Pregnosticon Pregnancy Test Kit is an agglutination method device designed for the detection of human chorionic gonadotropin. It functions as a clinical chemistry diagnostic tool to assist in the determination of pregnancy.
This device is classified as a Class 2 medical device under regulation number 862.1155. It received FDA 510(k) clearance under the traditional pathway with the submission number K790734.
Frequently asked questions
What is the primary function of the Pregnosticon Pregnancy Test Kit?
This device is a clinical chemistry diagnostic tool designed to detect human chorionic gonadotropin. By identifying this hormone, the kit assists clinicians in the determination of pregnancy.
What is the regulatory classification of this device?
The Pregnosticon Pregnancy Test Kit is classified as a Class 2 medical device under regulation number 862.1155. It received FDA 510(k) clearance through the traditional pathway under submission number K790734.
What testing method does this kit utilize?
This kit utilizes an agglutination method to perform its diagnostic function. This specific technique is categorized under the clinical chemistry medical specialty to facilitate the detection of human chorionic gonadotropin.
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: PREGNOSTICON PREGNANCY TEST KIT 510 (k) K790734 - FDA.report, K790734 FDA 510 (k) - PREGNOSTICON PREGNANCY TEST KIT, PREGNOSTICON PREGNANCY TEST KIT (K790734) — FDA 510 (k) | Innolitics, PREGNOSTICON PREGNANCY TEST KIT 510 (k) K790734 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K790734 | Class II | Active |
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Manufacturer
- Manufacturer
- Organon, Inc.
Sources (1)
- FDA 510(k) K790734 24 fields · synced Sep 24, 2026