Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests
FDA 510(k) K112101 · Polymed Therapeutics, Inc.
510(k) numberK112101
Submission
- Device name
- Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests
- Applicant
- Polymed Therapeutics, Inc.
Mission Viejo, CA, US - Received
- July 22, 2011
- Decision date
- July 17, 2012
- 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 |
| 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 |
|---|---|---|
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | 09/25/2014SE |
| K132834 | Fastep S10 HCG Serum/Urine Combo TestJHI · Traditional | 01/09/2014SE |
| K121065 | Polymed Therapeutics Fastep Dipstick Drugs of Abuse Screen Device and Dipcard Drugs of…DKZ · Traditional | 05/24/2013SE |
| K122907 | Fastep At-Home Pregnancy, HCG, Over the CounterLCX · Traditional | 03/14/2013SE |
Questions and answers
When was Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests cleared by the FDA?
Fastep HCG Pregancy Serum/Urine Cassette and Dipstick Tests (K112101) received a 510(k) decision of Substantially Equivalent on July 17, 2012, 361 days after the submission was received.
What is the product code of K112101?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.