DSL Active Androstenedione Ria (DSL #3800)
FDA 510(k) K854650 · Diagnostic Systems Laboratories, Inc.
510(k) numberK854650
Submission
- Device name
- DSL Active Androstenedione Ria (DSL #3800)
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- November 19, 1985
- Decision date
- December 13, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIZ – Radioimmunoassay, Androstenedione
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1075
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K963002 | Active Androstenedione EiaCIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 08/16/1996SE |
| K954755 | Coat-A-Count Direct AndrostenedioneCIZ · Traditional | Diagnostic Products Corp. | 11/29/1995SE |
| K934751 | Active Androstanediol GlucuronideCIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 01/10/1994SE |
| K860559 | Androstenedione 125I Kit by RiaCIZ · Traditional | Immuchem Corp. | 03/14/1986SE |
| K854673 | DSL Androstenedione Ria (DSL # 4200)CIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 01/22/1986SE |
| K844398 | Coat-A-Count Androstenedione Ria KitCIZ · Traditional | Diagnostic Products Corp. | 12/10/1984SE |
| K842960 | Androstenedione by RiaCIZ · Traditional | Radioassay Systems Laboratories, Inc. | 09/27/1984SE |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | Wien Laboratories, Inc. | 09/12/1983SE |
| K801729 | Androstenedione Radioimmunoassay KitCIZ · Traditional | Diagnostics Biochem Canada, Inc. | 10/31/1980SE |
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| 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 Active Androstenedione Ria (DSL #3800) cleared by the FDA?
DSL Active Androstenedione Ria (DSL #3800) (K854650) received a 510(k) decision of Substantially Equivalent on December 13, 1985, 24 days after the submission was received.
What is the product code of K854650?
The FDA product code is CIZ – Radioimmunoassay, Androstenedione, a Class I (low risk) device regulated under 21 CFR 862.1075.