DSL 7900 Active Dhea-S (DSL #7900)
FDA 510(k) K891478 · Diagnostic Systems Laboratories, Inc.
510(k) numberK891478
Submission
- Device name
- DSL 7900 Active Dhea-S (DSL #7900)
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- March 16, 1989
- Decision date
- April 26, 1989
- 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 |
More from Elias U.S.A., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061758 | Active Renin IrmaCIB · Special | 07/28/2006SE |
| K020945 | Axsym Intact PTH, Model 2G06CEW · Traditional | 05/31/2002SE |
| K020128 | Active Free Beta-Hcg Elisa, Model DSL-10-8500JHI · Traditional | 03/01/2002SE |
| K002128 | Active Inhibin-A Elisa, Model DSL-10-28100NDR · Traditional | 12/05/2000SE |
| K001086 | Free Testosterone Enzyme Immunoassay, Model DSL-10-4900CDZ · Traditional | 05/18/2000SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | 06/21/1999SE |
| K981871 | C-Reactive Protein Elisa, Model Number DSL-10-42100DCK · Traditional | 11/09/1998SE |
| K973244 | Active Psa Irma (DSL-9700)LTJ · Traditional | 08/03/1998SE |
| K973243 | Active Psa Elisa (DSL-10-9700)LTJ · Traditional | 08/03/1998SE |
| K981607 | Active Renin Irma Model Number DSL-25100CIB · Traditional | 05/27/1998SE |
Questions and answers
When was DSL 7900 Active Dhea-S (DSL #7900) cleared by the FDA?
DSL 7900 Active Dhea-S (DSL #7900) (K891478) received a 510(k) decision of Substantially Equivalent on April 26, 1989, 41 days after the submission was received.
What is the product code of K891478?
The FDA product code is JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), a Class I (low risk) device regulated under 21 CFR 862.1245.