Corning Magic Mab HCG Radioimmunoassay
FDA 510(k) K854024 · Corning Medical & Scientific
510(k) numberK854024
Submission
- Device name
- Corning Magic Mab HCG Radioimmunoassay
- Applicant
- Corning Medical & Scientific
Medfield, MA, US - Received
- September 30, 1985
- Decision date
- November 26, 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 |
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| K863789 | Corning Elisa PlatesLIB · Traditional | 10/03/1986SE |
| K853634 | Corning Cell Wells-Multiple Well PlatesKIZ · Traditional | 09/16/1985SE |
| K851939 | Corning Certain -IseJIX · Traditional | 06/14/1985SE |
| K851329 | Magic Monoclonal Antibody Tsh(Mab Tsh)RadioimmunoaJLW · Traditional | 06/13/1985SE |
| K850806 | Corning Blood Collection Capillary TubesGIO · Traditional | 03/25/1985SE |
| K850617 | Corning 780 Fluorometer/DensitometerJQT · Traditional | 03/12/1985SE |
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Questions and answers
When was Corning Magic Mab HCG Radioimmunoassay cleared by the FDA?
Corning Magic Mab HCG Radioimmunoassay (K854024) received a 510(k) decision of Substantially Equivalent on November 26, 1985, 57 days after the submission was received.
What is the product code of K854024?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.