HCG Maiaclone Immunoradiometric Kit/Kit Components
FDA 510(k) K862262 · Serono Diagnostics, Inc.
510(k) numberK862262
Submission
- Device name
- HCG Maiaclone Immunoradiometric Kit/Kit Components
- Applicant
- Serono Diagnostics, Inc.
Norwell, MA, US - Received
- June 13, 1986
- Decision date
- July 29, 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 |
More from Polymed Therapeutics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953598 | Series 9100 Plus Automated Differential Hematology AnalyzersGKZ · Traditional | 03/11/1996SE |
| K942051 | SR1 Dhea-S Enzyme ImmunoassayJKC · Traditional | 07/13/1994SE |
| K883085 | T3 Uptake Serozyme Enzyme Immuno Kt/Mag Solid PhasKHQ · Traditional | 09/09/1988SE |
| K882340 | LH Serozyme Immunoenzymetric Assay Kit,Mag Sol PhaCEP · Traditional | 08/08/1988SE |
| K880388 | T3 Serozyme Enzymeimmunoassay Kit, Mag Solid PhaseCDP · Traditional | 03/03/1988SE |
| K874866 | T4 Serozyme Enzymeimmunoassay Kit/Mag. Solid PhaseKLI · Traditional | 02/11/1988SE |
| K873431 | Progesterone Maia Radioimmuno Assay Kit Mag SLD PHJLS · Traditional | 10/20/1987SE |
| K873186 | LH Maiaclone Immunoradio. Assay Kit, Mag Solid PhaCEP · Traditional | 09/29/1987SE |
| K873400 | Prolactin Maiaclone Immunoradio. Kit, Mag Sol PhaCFT · Traditional | 09/25/1987SE |
| K872862 | PRL Serozyme Immunoenz. Assay Kit, Mag. Solid PhasCFT · Traditional | 09/18/1987SE |
Questions and answers
When was HCG Maiaclone Immunoradiometric Kit/Kit Components cleared by the FDA?
HCG Maiaclone Immunoradiometric Kit/Kit Components (K862262) received a 510(k) decision of Substantially Equivalent on July 29, 1986, 46 days after the submission was received.
What is the product code of K862262?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.