Modified Chorio-Shure
FDA 510(k) K832892 · Nuclear Medical Laboratories, Inc.
510(k) numberK832892
Submission
- Device name
- Modified Chorio-Shure
- Applicant
- Nuclear Medical Laboratories, Inc.
Mchenry, IL, US - Received
- August 26, 1983
- Decision date
- October 28, 1983
- 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 |
|---|---|---|
| K852438 | NML TSH IrmaJLW · Traditional | 07/12/1985SE |
| K844583 | Tsh-StatJLW · Traditional | 03/05/1985SE |
| K840466 | NML Cortisol RiaCGR · Traditional | 03/30/1984SE |
| K840589 | Tri-Tube RiaKHQ · Traditional | 03/09/1984SE |
| K832002 | NML-5010/5020 Multi-Detector SystemJJJ · Traditional | 08/08/1983SE |
| K823679 | NML 6000 CTJQP · Traditional | 01/07/1983SE |
| K823053 | Nml-Tetra-Tube RiaCDX · Traditional | 11/10/1982SE |
| K822298 | Diagnostic Radioimmunoassay for QuantiJFH · Traditional | 09/02/1982SE |
| K820523 | Chorio-QuantJHI · Traditional | 03/15/1982SE |
| K812759 | NML Ck-Mb RiaJHX · Traditional | 10/19/1981SE |
Questions and answers
When was Modified Chorio-Shure cleared by the FDA?
Modified Chorio-Shure (K832892) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 63 days after the submission was received.
What is the product code of K832892?
The FDA product code is JHI – Visual, Pregnancy Hcg, Prescription Use, a Class II (moderate risk) device regulated under 21 CFR 862.1155.