Active Androstenedione Eia
FDA 510(k) K963002 · Diagnostic Systems Laboratories, Inc.
510(k) numberK963002
Submission
- Device name
- Active Androstenedione Eia
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- August 2, 1996
- Decision date
- August 16, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| 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 |
| K801729 | Androstenedione Radioimmunoassay KitCIZ · Traditional | Diagnostics Biochem Canada, Inc. | 10/31/1980SE |
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Questions and answers
When was Active Androstenedione Eia cleared by the FDA?
Active Androstenedione Eia (K963002) received a 510(k) decision of Substantially Equivalent on August 16, 1996, 14 days after the submission was received.
What is the product code of K963002?
The FDA product code is CIZ – Radioimmunoassay, Androstenedione, a Class I (low risk) device regulated under 21 CFR 862.1075.