Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
FDA 510(k) K152768 · Assure Tech. Co., Ltd.
510(k) numberK152768
Submission
- Device name
- Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip
- Applicant
- Assure Tech. Co., Ltd.
Hangzhou, CN - Received
- September 24, 2015
- Decision date
- February 24, 2016
- 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 |
| 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 |
| K112315 | Home Pregnancy TestJHI · Traditional | Newscen Coast Bio-Pharmaceutical Co., Ltd. | 04/23/2012SE |
More from Newscen Coast Bio-Pharmaceutical Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261984 | AssureTech Quick Cup Tests;AssureTech Multi-drug Urine Test CupNFT · Traditional | 07/17/2026SE |
| K260754 | Fastep COVID-19 Antigen Pen Home Test; Fastep COVID-19 Antigen Pen TestQYT · Traditional | 06/05/2026SE |
| K252259 | AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test CupNFT · Traditional | 08/15/2025SE |
| K250117 | FaStep Pregnancy Rapid Test Cassette; Fastep HCG Rapid Test CassetteLCX · Traditional | 02/13/2025SE |
| K243996 | AssureTech Panel Dip Tests; AssureTech Quick Cup Tests; AssureTech Multi-drug Urine Test…NFT · Traditional | 02/07/2025SE |
| K243573 | FaStep Early Pregnancy Rapid Test Strip; FaStep Early Pregnancy Rapid Test Cassette…LCX · Traditional | 01/15/2025SE |
| K240351 | FaStep Fentanyl Rapid Test Device (Urine); FaStep Rapid Fentanyl Urine Test (Urine)NGL · Traditional | 03/06/2024SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | 10/05/2015SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | 06/04/2015SE |
Questions and answers
When was Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip cleared by the FDA?
Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip (K152768) received a 510(k) decision of Substantially Equivalent on February 24, 2016, 153 days after the submission was received.
What is the product code of K152768?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.