Radioimmunoassay, Human Chorrionic
FDA 510(k) K822840 · Bioclinical Group
510(k) numberK822840
Submission
- Device name
- Radioimmunoassay, Human Chorrionic
- Applicant
- Bioclinical Group
Mchenry, IL, US - Received
- September 23, 1982
- Decision date
- October 27, 1982
- 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 |
|---|---|---|
| K862968 | Free T3 Radioimmunoassay KitKHQ · Traditional | 09/25/1986SE |
| K853837 | Lh/Fsh Radioimmunoassay KitCEP · Traditional | 10/16/1985SE |
| K832638 | Cortisol Radioimmunoassay KitCGR · Traditional | 09/12/1983SE |
| K823005 | Bio Mag Free T4 Radioimmunoassay KitCEC · Traditional | 12/15/1982SE |
| K823004 | Bio Mag Total T4 Radioimmunoassay KitCDX · Traditional | 11/05/1982SE |
| K822515 | B-Hcg Radioimmunoassay KitJHI · Traditional | 09/14/1982SE |
| K821241 | Free T4 Radioimmunoassay KitCEC · Traditional | 06/01/1982SE |
| K821101 | Total Radioimmunoassay KitCDX · Traditional | 05/05/1982SE |
Questions and answers
When was Radioimmunoassay, Human Chorrionic cleared by the FDA?
Radioimmunoassay, Human Chorrionic (K822840) received a 510(k) decision of Substantially Equivalent on October 27, 1982, 34 days after the submission was received.
What is the product code of K822840?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.