HCG Ria Test System
FDA 510(k) K854958 · Monobind
510(k) numberK854958
Submission
- Device name
- HCG Ria Test System
- Applicant
- Monobind
Costa Mesa, CA, US - Received
- December 11, 1985
- Decision date
- January 28, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| K030860 | Accubind Neonatal T4 Microplate Eia, Model 2625-300KLI · Traditional | 08/22/2003SE |
| K020548 | Free T4 (Thytoxine) Microplate Eia Test Models # 1225-300CEC · Traditional | 04/05/2002SE |
| K980088 | T-Uptake Microplate EiaKHQ · Traditional | 02/04/1998SE |
| K972720 | Follicle Stimulating Hormone (FSH) Microplate Elisa (425-300)CGJ · Traditional | 09/02/1997SE |
| K971835 | Anti-Thyroglobulin (TG) Microplate ElisaDDC · Traditional | 07/03/1997SE |
| K971834 | Anti-Thyroid Peroxidase (Tpo) Microplate ElisaJNL · Traditional | 07/03/1997SE |
| K971921 | Prolactin (PRL) Hormone Microplate ElisaCFT · Traditional | 06/24/1997SE |
| K971780 | Thyrotropin(Tsh) ElisaJLW · Traditional | 06/24/1997SE |
Questions and answers
When was HCG Ria Test System cleared by the FDA?
HCG Ria Test System (K854958) received a 510(k) decision of Substantially Equivalent on January 28, 1986, 48 days after the submission was received.
What is the product code of K854958?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.