Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo Serum/Urine Cassette Test
FDA 510(k) K123844 · Chemtron Biotech, Inc.
510(k) numberK123844
Submission
- Device name
- Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo Serum/Urine Cassette Test
- Applicant
- Chemtron Biotech, Inc.
San Diego, CA, US - Received
- December 13, 2012
- Decision date
- May 30, 2013
- 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 |
| 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 |
|---|---|---|
| K232736 | Chemtrue® Drug Screen Fentanyl/Tramadol Cup Test, Chemtrue® Drug Screen…DJG · Traditional | 12/20/2023SE |
| K153192 | Chemtrue Multi-Panel Drug Screen Dip Card/Cup Tests, Chemtrue Multi-Panel Drug Screen…DJG · Traditional | 04/18/2016SE |
| K143599 | Chemtrue Drug Screen Cup Tests and Chemtrue Drug Screen Cup Tests with OPI 2000DJG · Traditional | 04/17/2015SE |
| K142580 | Chemtrue Multi-Panel DOA DIP Card TestsDKZ · Special | 12/01/2014SE |
| K142396 | Chemtrue BUP/TCA Single/Multi-Panel Drug Screen Dip Card/Cup/Cassette TestsDJG · Traditional | 10/09/2014SE |
| K131931 | Chemtrue(R) HCG Pregnancy Urine Midstream TestLCX · Traditional | 07/26/2013SE |
| K123080 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/ Cassette TestsJXM · Traditional | 11/29/2012SE |
| K121339 | Chemtrue Single/Multi-Panel Drug Screen Dip Card/Cassette TestsDKZ · Traditional | 05/17/2012SE |
| K111322 | Chemtrue Single/Multi-Panel Drug Screen Cassette/DipcardJXM · Traditional | 09/14/2011SE |
| K102203 | Chemtrue Single / Multi Drug Screen Cassette / Dip Card TestsDKZ · Traditional | 01/20/2011SE |
Questions and answers
When was Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo Serum/Urine Cassette Test cleared by the FDA?
Chemtrue HCG Pregnancy Urine Dipstick, HCG Pregnancy Urine Cassette Test, and HCG Combo Serum/Urine Cassette Test (K123844) received a 510(k) decision of Substantially Equivalent on May 30, 2013, 168 days after the submission was received.
What is the product code of K123844?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.