MRI Hcg-Beta Ria Kit Cat. #MR-10100
FDA 510(k) K801491 · Microanalytic Research, Inc.
510(k) numberK801491
Submission
- Device name
- MRI Hcg-Beta Ria Kit Cat. #MR-10100
- Applicant
- Microanalytic Research, Inc.
Mchenry, IL, US - Received
- June 26, 1980
- Decision date
- August 13, 1980
- 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 |
|---|---|---|
| K861097 | Trypsin Ria KitJNO · Traditional | 05/29/1986SE |
| K820741 | MR1 Lutropin Ria KitCEP · Traditional | 04/14/1982SE |
| K820740 | MR1 Follitropin Ria KitCGJ · Traditional | 04/06/1982SE |
| K813516 | MRI Tobramycin Ria KitKLB · Traditional | 12/29/1981SE |
| K812394 | MRI Gentamicin Ria KitDJB · Traditional | 09/08/1981SE |
| K810949 | MRI Prolactin Ria KitCFT · Traditional | 07/10/1981SE |
| K802754 | Immunoreactive Estriol Ria KitCGI · Traditional | 01/21/1981SE |
Questions and answers
When was MRI Hcg-Beta Ria Kit Cat. #MR-10100 cleared by the FDA?
MRI Hcg-Beta Ria Kit Cat. #MR-10100 (K801491) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 48 days after the submission was received.
What is the product code of K801491?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.