Sopheia DHEA-SO4 Eia Kit
FDA 510(k) K852847 · Diagnostic Products Corp.
510(k) numberK852847
Submission
- Device name
- Sopheia DHEA-SO4 Eia Kit
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- July 5, 1985
- Decision date
- August 2, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1245
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JKC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040181 | Access Dhea-S Reagent AssayJKC · Abbreviated | Beckman Coulter, Inc. | 03/24/2004SE |
| K003174 | Elecsys Dhea-SJKC · Traditional | Roche Diagnostics Corp. | 01/17/2001SE |
| K973897 | Dhea-SJKC · Traditional | Kmi Diagnostics, Inc. | 11/13/1997SE |
| K962895 | DSL DHEA-S-7JKC · Traditional | Diagnostic Systems Laboratories, Inc. | 09/10/1996SE |
| K955114 | DSL Aactive Dhea Eia KitJKC · Traditional | Diagnostic Systems Laboratories, Inc. | 02/23/1996SE |
| K950524 | Nichols Institute Diagnostics Dhea-S Chemiluminescence ImmunoassayJKC · Traditional | Nichols Institute | 05/15/1995SE |
| K942051 | SR1 Dhea-S Enzyme ImmunoassayJKC · Traditional | Serono Diagnostics, Inc. | 07/13/1994SE |
| K935014 | Active Dehydroepiandrosterone (Dhea)(Dsl 9000)JKC · Traditional | Diagnostic Systems Laboratories, Inc. | 05/09/1994SE |
| K935806 | Immulite DHEA-S04JKC · Traditional | Diagnostic Products Corp. | 04/26/1994SE |
| K935469 | Synelisa Dhea-SulfateJKC · Traditional | Elias U.S.A., Inc. | 03/22/1994SE |
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Questions and answers
When was Sopheia DHEA-SO4 Eia Kit cleared by the FDA?
Sopheia DHEA-SO4 Eia Kit (K852847) received a 510(k) decision of Substantially Equivalent on August 2, 1985, 28 days after the submission was received.
What is the product code of K852847?
The FDA product code is JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), a Class I (low risk) device regulated under 21 CFR 862.1245.