Immulite DHEA-S04
FDA 510(k) K935806 · Diagnostic Products Corp.
510(k) numberK935806
Submission
- Device name
- Immulite DHEA-S04
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- December 2, 1993
- Decision date
- April 26, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| K935469 | Synelisa Dhea-SulfateJKC · Traditional | Elias U.S.A., Inc. | 03/22/1994SE |
| K931601 | Chemiluminescence Dhea-S ImmunoassayJKC · Traditional | Nichols Institute | 07/27/1993SE |
More from Nichols Institute
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|---|---|---|
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| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite DHEA-S04 cleared by the FDA?
Immulite DHEA-S04 (K935806) received a 510(k) decision of Substantially Equivalent on April 26, 1994, 145 days after the submission was received.
What is the product code of K935806?
The FDA product code is JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), a Class I (low risk) device regulated under 21 CFR 862.1245.