Pro-Step HCG
FDA 510(k) K925125 · Disease Detection International, Inc.
510(k) numberK925125
Submission
- Device name
- Pro-Step HCG
- Applicant
- Disease Detection International, Inc.
Irvine, CA, US - Received
- October 13, 1992
- Decision date
- January 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|
| K943252 | Pro-Step LH Ovulation Prediction TestCEP · Traditional | 10/25/1994SE |
| K925303 | Pro-Step PT HCGJHI · Traditional | 06/15/1993SE |
| K911826 | Immunocard HCG One Step (I-S) Test KitJHI · Traditional | 07/19/1991SE |
| K902571 | Modification of Serocard Rubella Igg TestLFX · Traditional | 09/05/1990SE |
| K903070 | Serocard HSV Igg Antibody Test KitLGC · Traditional | 08/09/1990SE |
| K895912 | Immunocard HCG Ii-S Test KitJHI · Traditional | 12/01/1989SE |
| K896109 | Immunocard Strep a TestGTZ · Traditional | 11/29/1989SE |
| K884249 | Modified Ddi Serocard Toxoplasma Igg Test KitLGD · Traditional | 04/10/1989SE |
| K884248 | Modified Ddi Serocard CMV Igg Test KitLFZ · Traditional | 04/10/1989SE |
| K884247 | Modified Ddi Serocard Rubella Igg Test KitLFX · Traditional | 04/10/1989SE |
Questions and answers
When was Pro-Step HCG cleared by the FDA?
Pro-Step HCG (K925125) received a 510(k) decision of Substantially Equivalent on January 13, 1993, 92 days after the submission was received.
What is the product code of K925125?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.