Androstenedione Radioimmunoassay Kit
FDA 510(k) K801729 · Diagnostics Biochem Canada, Inc.
510(k) numberK801729
Submission
- Device name
- Androstenedione Radioimmunoassay Kit
- Applicant
- Diagnostics Biochem Canada, Inc.
Mchenry, IL, US - Received
- July 24, 1980
- Decision date
- October 31, 1980
- 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 |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | Wien Laboratories, Inc. | 09/12/1983SE |
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|---|---|---|
| K030730 | Free Testosterone Enzymeimmunoassay (Eia) KitCDZ · Traditional | 08/18/2003SE |
| K014120 | Testosterone by Enzymeimmunoassay (Eia)CDZ · Traditional | 02/08/2002SE |
| K864966 | Estrone Analysis Products Radioimmunoassay EstroneCGF · Traditional | 01/09/1987SE |
| K832297 | HYDROXYPROGESTERONE-17JLS · Traditional | 09/01/1983SE |
| K781310 | Human Chorionic Gonado.-Beta Ria KitJHI · Traditional | 08/31/1978SE |
Questions and answers
When was Androstenedione Radioimmunoassay Kit cleared by the FDA?
Androstenedione Radioimmunoassay Kit (K801729) received a 510(k) decision of Substantially Equivalent on October 31, 1980, 99 days after the submission was received.
What is the product code of K801729?
The FDA product code is CIZ – Radioimmunoassay, Androstenedione, a Class I (low risk) device regulated under 21 CFR 862.1075.