Dhea-Sulfate Test Set
FDA 510(k) K792041 · Wien Laboratories, Inc.
510(k) numberK792041
Submission
- Device name
- Dhea-Sulfate Test Set
- Applicant
- Wien Laboratories, Inc.
Mchenry, IL, US - Received
- October 12, 1979
- Decision date
- October 30, 1979
- 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 |
|---|---|---|
| K912850 | SHBGCDZ · Traditional | 08/12/1991SE |
| K834246 | Progesterone Test Set 125I 17-OHJLX · Traditional | 02/04/1984SE |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | 09/12/1983SE |
| K823200 | 125 I-Dehydroepiandrosterone SulfateJKC · Traditional | 11/29/1982SE |
| K821653 | Protriptyline Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K821652 | Doxepin Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K802728 | 125I-TESTOSTERONE Test SetCDZ · Traditional | 12/11/1980SE |
| K781834 | Test Set, 125 I-DigoxinDNL · Traditional | 01/03/1979SE |
| K781599 | I-Estriol Test SetCGI · Traditional | 10/17/1978SE |
| K772306 | 125I Digoxin Test SetDPB · Traditional | 12/22/1977SE |
Questions and answers
When was Dhea-Sulfate Test Set cleared by the FDA?
Dhea-Sulfate Test Set (K792041) received a 510(k) decision of Substantially Equivalent on October 30, 1979, 18 days after the submission was received.
What is the product code of K792041?
The FDA product code is JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), a Class I (low risk) device regulated under 21 CFR 862.1245.