Androstenedione Test Set 125I
FDA 510(k) K832452 · Wien Laboratories, Inc.
510(k) numberK832452
Submission
- Device name
- Androstenedione Test Set 125I
- Applicant
- Wien Laboratories, Inc.
Mchenry, IL, US - Received
- July 25, 1983
- Decision date
- September 12, 1983
- 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 |
| K854650 | DSL Active Androstenedione Ria (DSL #3800)CIZ · Traditional | Diagnostic Systems Laboratories, Inc. | 12/13/1985SE |
| 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 |
| K801729 | Androstenedione Radioimmunoassay KitCIZ · Traditional | Diagnostics Biochem Canada, Inc. | 10/31/1980SE |
More from Diagnostics Biochem Canada, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912850 | SHBGCDZ · Traditional | 08/12/1991SE |
| K834246 | Progesterone Test Set 125I 17-OHJLX · Traditional | 02/04/1984SE |
| 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 |
| K792041 | Dhea-Sulfate Test SetJKC · Traditional | 10/30/1979SE |
| 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 Androstenedione Test Set 125I cleared by the FDA?
Androstenedione Test Set 125I (K832452) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 49 days after the submission was received.
What is the product code of K832452?
The FDA product code is CIZ – Radioimmunoassay, Androstenedione, a Class I (low risk) device regulated under 21 CFR 862.1075.