Quantrols HCG
FDA 510(k) K772086 · Organon, Inc.
510(k) numberK772086
Submission
- Device name
- Quantrols HCG
- Applicant
- Organon, Inc.
Mchenry, IL, US - Received
- November 3, 1977
- Decision date
- November 23, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JHI – Visual, Pregnancy Hcg, Prescription Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1155
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JHI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241919 | Innovita HCG Pregnancy Rapid Combo TestJHI · Traditional | Innovita (Tangshan) Biological Technology Co.… | 08/02/2024SE |
| K203272 | Alltest Pregnancy Rapid Combo Test CassetteJHI · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 01/31/2022SE |
| K172322 | Atellica IM Total hCG (ThCG)JHI · Traditional | Siemens Healthcare Diagnostics, Inc. | 03/29/2018SE |
| K172257 | TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result…JHI · Traditional | True Diagnostics, Inc. | 12/22/2017SE |
| K152768 | Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy…JHI · Traditional | Assure Tech. Co., Ltd. | 02/24/2016SE |
| K130456 | Wunder Pregnancy TestJHI · Traditional | James Nguyen | 04/08/2014SE |
| K132834 | Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional | Polymed Therapeutics, Inc. | 01/09/2014SE |
| K131166 | Sofia(R) HCG FiaJHI · Traditional | Quidel Corp. | 08/02/2013SE |
| K123844 | Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo…JHI · Traditional | Chemtron Biotech, Inc. | 05/30/2013SE |
| K112101 | Fastep HCG Pregancy Serum/Urine Cassette and Dipstick TestsJHI · Traditional | Polymed Therapeutics, Inc. | 07/17/2012SE |
More from Polymed Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253642 | Jada System (Jada-2002)OQY · Traditional | 05/15/2026SE |
| K950861 | Reconstitution AccessoreisFPK · Traditional | 05/26/1995SE |
| K853388 | Monosticon Uni-DotKTN · Traditional | 08/22/1985SE |
| K842314 | Duoclon Color-CeptJHJ · Traditional | 08/24/1984SE |
| K841525 | Oreia II B-Hcg Pregnancy Test KitJHI · Traditional | 06/05/1984SE |
| K841602 | Accurate Beta 30 Pregnancy Test KitLCX · Traditional | 05/22/1984SE |
| K840650 | B-Neocept 30JHJ · Traditional | 04/04/1984SE |
| K832801 | Oreia II B-Hcg, Enzyme InnunoassayJHI · Traditional | 12/08/1983SE |
| K831339 | Neo-Pregnosticon Duoclon Tube TestJHJ · Traditional | 06/08/1983SE |
| K831109 | Duoclon Slide TestJHI · Traditional | 06/02/1983SE |
Questions and answers
When was Quantrols HCG cleared by the FDA?
Quantrols HCG (K772086) received a 510(k) decision of Substantially Equivalent on November 23, 1977, 20 days after the submission was received.
What is the product code of K772086?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.