Model Serum HCG Assay
FDA 510(k) K850730 · Monoclonal Antibodies, Inc.
510(k) numberK850730
Submission
- Device name
- Model Serum HCG Assay
- Applicant
- Monoclonal Antibodies, Inc.
Mountain View, CA, US - Received
- February 22, 1985
- Decision date
- April 2, 1985
- 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 |
|---|---|---|
| K874863 | Ramp Herpes Simplex Virus (HSV) (CCT)GQN · Traditional | 02/16/1988SE |
| K871726 | Ovuquick Self-Test (Ovuquick; Ramp LH Assay)CEP · Traditional | 07/27/1987SE |
| K863744 | HCG Control KitJJX · Traditional | 11/05/1986SE |
| K860924 | Ramp Progesturine PDG ASSAY--48 Test KitJLS · Traditional | 07/02/1986SE |
| K854611 | Ramp Urine HCG AssayJHI · Traditional | 12/30/1985SE |
| K850480 | Ovu Stick Self-Test -ModificationCEP · Traditional | 03/05/1985SE |
| K843284 | Ovustick Self-TestCEP · Traditional | 12/11/1984SE |
| K840738 | Plus Urine HCG AssayJHJ · Traditional | 04/19/1984SE |
| K840412 | Ovu Stick Urine HLH KitCEP · Traditional | 04/13/1984SE |
| K833504 | Pregnastick Urine HCG KitJHJ · Traditional | 01/09/1984SE |
Questions and answers
When was Model Serum HCG Assay cleared by the FDA?
Model Serum HCG Assay (K850730) received a 510(k) decision of Substantially Equivalent on April 2, 1985, 39 days after the submission was received.
What is the product code of K850730?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.