Pantex Direct Dhea-S Coated Tube Radioimmunoassay
FDA 510(k) K853867 · Pantex, Div. Bio-Analysis, Inc.
510(k) numberK853867
Submission
- Device name
- Pantex Direct Dhea-S Coated Tube Radioimmunoassay
- Applicant
- Pantex, Div. Bio-Analysis, Inc.
Santa Monica, CA, US - Received
- September 17, 1985
- Decision date
- October 4, 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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| K102841 | Pantex Am/Pm Salivary Cortisol Enzyme ImmunoassayNHG · Traditional | 05/08/2012SE |
| K942658 | Neoscreen Elisa TSHJLW · Traditional | 02/24/1995SE |
| K914107 | Prolactin Irma ImmunomagCFT · Traditional | 09/30/1991SE |
| K912804 | FSH Irma ImmunomagCGJ · Traditional | 08/12/1991SE |
| K911839 | Neonatal Blood Spot Test 17-HYDROXPROG Radio KitJLX · Traditional | 06/18/1991SE |
| K911050 | LH Irma ImmunomagCEP · Traditional | 04/12/1991SE |
| K910717 | Pantex Irma LH 1251 KitCEP · Traditional | 03/19/1991SE |
| K894049 | Immunocoat Progesterone Radioimmunoassay KitJLS · Traditional | 09/08/1989SE |
| K862483 | Pantex Fte Free Testosterone Radioimmunoassay KitCDZ · Traditional | 01/14/1987SE |
| K862447 | Pancoat T3 Uptake Coated Tube Radioimmunoassay KitKHQ · Traditional | 10/07/1986SE |
Questions and answers
When was Pantex Direct Dhea-S Coated Tube Radioimmunoassay cleared by the FDA?
Pantex Direct Dhea-S Coated Tube Radioimmunoassay (K853867) received a 510(k) decision of Substantially Equivalent on October 4, 1985, 17 days after the submission was received.
What is the product code of K853867?
The FDA product code is JKC – Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate), a Class I (low risk) device regulated under 21 CFR 862.1245.