Androstenedione by Ria
FDA 510(k) K842960 · Radioassay Systems Laboratories, Inc.
510(k) numberK842960
Submission
- Device name
- Androstenedione by Ria
- Applicant
- Radioassay Systems Laboratories, Inc.
Mchenry, IL, US - Received
- July 27, 1984
- Decision date
- September 27, 1984
- 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 |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | Wien Laboratories, Inc. | 09/12/1983SE |
| K801729 | Androstenedione Radioimmunoassay KitCIZ · Traditional | Diagnostics Biochem Canada, Inc. | 10/31/1980SE |
More from Diagnostics Biochem Canada, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K862204 | RSL (125I) Aldosterone KitCJM · Traditional | 09/25/1986SE |
| K840886 | Hydroxyprogesterone by Ria 17AJLS · Traditional | 04/18/1984SE |
| K831855 | Hatch KitCKG · Traditional | 07/28/1983SE |
| K802195 | Dehydroepiandrosterone Sulfate Kit RiaJKC · Traditional | 10/23/1980SE |
| K800126 | RSL (125 L) Progesterone KitJLS · Traditional | 02/13/1980SE |
| K791999 | (125I) Testosterone KitCDZ · Traditional | 10/30/1979SE |
| K791835 | Coralent Coat 125I Cortisol Radioimm.CGR · Traditional | 09/27/1979SE |
| K791740 | Serum 11-DESOXYCORTISOL I AS TracerJKB · Traditional | 09/27/1979SE |
| K791728 | Rsl's Assay Procedure QuantitationCGI · Traditional | 09/27/1979SE |
| K791652 | Estradiol Kit by RiaCHP · Traditional | 09/27/1979SE |
Questions and answers
When was Androstenedione by Ria cleared by the FDA?
Androstenedione by Ria (K842960) received a 510(k) decision of Substantially Equivalent on September 27, 1984, 62 days after the submission was received.
What is the product code of K842960?
The FDA product code is CIZ – Radioimmunoassay, Androstenedione, a Class I (low risk) device regulated under 21 CFR 862.1075.