Radioimmunoassay, Androstenedione
The Radioimmunoassay, Androstenedione test system (product code CIZ) is an in-vitro diagnostic device used in clinical chemistry to measure androstenedione, an intermediate androgen hormone, in serum using a radioimmunoassay method, aiding in the evaluation of adrenal and gonadal androgen production and disorders such as polycystic ovary syndrome. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1075 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CIZ
- Device Class
- FDA class 1
- Regulation Number
- 862.1075
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K963002 | ACTIVE ANDROSTENEDIONE EIA | Aug 16, 1996 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K954755 | COAT-A-COUNT DIRECT ANDROSTENEDIONE | Nov 29, 1995 | Substantially Equivalent | Diagnostic Products Corp. |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | Jan 10, 1994 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Mar 14, 1986 | Substantially Equivalent | Immuchem Corp. |
| K854673 | DSL ANDROSTENEDIONE RIA (DSL # 4200) | Jan 22, 1986 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K854650 | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) | Dec 13, 1985 | Substantially Equivalent | Diagnostic Systems Laboratories, Inc. |
| K844398 | COAT-A-COUNT ANDROSTENEDIONE RIA KIT | Dec 10, 1984 | Substantially Equivalent | Diagnostic Products Corp. |
| K842960 | ANDROSTENEDIONE BY RIA | Sep 27, 1984 | Substantially Equivalent | Radioassay Systems Laboratories, Inc. |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Sep 12, 1983 | Substantially Equivalent | Wien Laboratories, Inc. |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Oct 31, 1980 | Substantially Equivalent | Diagnostics Biochem Canada, Inc. |
FEI Numbers
This FDA classification entry is associated with 19 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 19 registration numbers. Click on an entry to view related FDA registrations.