Excel Onestep Urine HCG Module Pregnancy Test
FDA 510(k) K963231 · Excel Scientific, Inc.
510(k) numberK963231
Submission
- Device name
- Excel Onestep Urine HCG Module Pregnancy Test
- Applicant
- Excel Scientific, Inc.
Yorba Linda, CA, US - Received
- August 19, 1996
- Decision date
- December 4, 1996
- 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 |
|---|---|---|
| K971286 | Ez Sure (Excel) Urine Midstream Pregnancy Home TestLCX · Traditional | 05/08/1997SE |
| K970467 | Ez Sure One Step Ovulation Predictor Home Test KitCEP · Traditional | 03/18/1997SE |
| K970425 | Ez Sure Urine Dipstick Pregnancy Home TestLCX · Traditional | 03/06/1997SE |
| K970424 | Excel One Step Urine HCG Pregnancy Dipstick TestJHI · Traditional | 03/06/1997SE |
| K962146 | Excel Onestep Group a Strep Antigen Module Test KitGTZ · Traditional | 10/07/1996SE |
| K962580 | Ez Sure Onestep Early Pregnancy TestLCX · Traditional | 08/29/1996SE |
| K955707 | Onestep Urine/Serum HCG Module Pregnancy Test KitDHA · Traditional | 05/02/1996SE |
Questions and answers
When was Excel Onestep Urine HCG Module Pregnancy Test cleared by the FDA?
Excel Onestep Urine HCG Module Pregnancy Test (K963231) received a 510(k) decision of Substantially Equivalent on December 4, 1996, 107 days after the submission was received.
What is the product code of K963231?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.