Advantage HCG Test (Urine/Serum)
FDA 510(k) K994227 · Advantage Diagnostics Corp.
510(k) numberK994227
Submission
- Device name
- Advantage HCG Test (Urine/Serum)
- Applicant
- Advantage Diagnostics Corp.
Mountian View, CA, US - Received
- December 15, 1999
- Decision date
- February 3, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K023712 | Advantage Multiple Drugs of Abuse TestDKZ · Traditional | 01/31/2003SE |
| K013778 | Peace of Mind Home Drug TestMVO · Traditional | 02/07/2002SE |
| K011962 | Advantage Marijuana (THC) and Cocaine Home Drug TestDIO · Traditional | 08/09/2001SE |
| K010921 | Advantage Marijuana (THC) Home Drug TestLDJ · Traditional | 06/25/2001SE |
| K003708 | Advantage Thc/Cocaine TestDIO · Traditional | 01/22/2001SE |
| K001567 | Advantage THC TestLDJ · Traditional | 06/19/2000SE |
| K991883 | Redi-Test OpiatesDJG · Traditional | 09/15/1999SE |
| K903416 | Cannula, SurgicalGEA · Traditional | 11/23/1990SE |
| K881369 | Advance Diagnostics Disposable EyecupLXQ · Traditional | 05/13/1988SE |
Questions and answers
When was Advantage HCG Test (Urine/Serum) cleared by the FDA?
Advantage HCG Test (Urine/Serum) (K994227) received a 510(k) decision of Substantially Equivalent on February 3, 2000, 50 days after the submission was received.
What is the product code of K994227?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.