HCG Ria Pregnancy Test
FDA 510(k) K791206 · Hoffmann-La Roche, Inc.
510(k) numberK791206
Submission
- Device name
- HCG Ria Pregnancy Test
- Applicant
- Hoffmann-La Roche, Inc.
Mchenry, IL, US - Received
- June 29, 1979
- Decision date
- July 30, 1979
- 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 |
More from Polymed Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K850727 | Bhcg-Roche EiaJHI · Traditional | 06/25/1985SE |
| K831694 | RenakCIB · Traditional | 07/19/1983SE |
| K830482 | Abuscreen Radioimmunoassay-AmphetamineDJP · Traditional | 03/24/1983SE |
| K830481 | Abuscreen Radioimmunoassay-PhencyclidineLCL · Traditional | 03/24/1983SE |
| K830480 | Abuscreen Radioimmunoassay-Cocaine MetaKLN · Traditional | 03/24/1983SE |
| K830462 | Abuscreen Radioummunoassay--UrineDOE · Traditional | 03/24/1983SE |
| K830461 | Abuscreen Radioummunoassay-MethaqualoneKXS · Traditional | 03/24/1983SE |
| K830460 | Abuscreen Radioimmunoassay for MorphineDOE · Traditional | 03/24/1983SE |
| K830479 | Abuscreen Radioimmunoassay-BarbiturateDKN · Traditional | 03/10/1983SE |
| K823580 | Cobas Reagent for Inorganic PhosphorusCEO · Traditional | 01/07/1983SE |
Questions and answers
When was HCG Ria Pregnancy Test cleared by the FDA?
HCG Ria Pregnancy Test (K791206) received a 510(k) decision of Substantially Equivalent on July 30, 1979, 31 days after the submission was received.
What is the product code of K791206?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.