CIZ — Radioimmunoassay, Androstenedione Class I
FDA product code CIZ covers "Radioimmunoassay, Androstenedione", a Class I medical device regulated under 21 CFR 862.1075. Submissions are reviewed by the Clinical Chemistry panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIZ
- Device Class
- Class I
- Regulation Number
- 862.1075
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K963002 | diagnostic systems laboratories | ACTIVE ANDROSTENEDIONE EIA | August 16, 1996 |
| K954755 | diagnostic products | COAT-A-COUNT DIRECT ANDROSTENEDIONE | November 29, 1995 |
| K934751 | diagnostic systems laboratories | ACTIVE ANDROSTANEDIOL GLUCURONIDE | January 10, 1994 |
| K860559 | immuchem | ANDROSTENEDIONE 125I KIT BY RIA | March 14, 1986 |
| K854673 | diagnostic systems laboratories | DSL ANDROSTENEDIONE RIA (DSL # 4200) | January 22, 1986 |
| K854650 | diagnostic systems laboratories | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) | December 13, 1985 |
| K844398 | diagnostic products | COAT-A-COUNT ANDROSTENEDIONE RIA KIT | December 10, 1984 |
| K842960 | radioassay systems laboratories | ANDROSTENEDIONE BY RIA | September 27, 1984 |
| K832452 | wien laboratories | ANDROSTENEDIONE TEST SET 125I | September 12, 1983 |
| K801729 | diagnostics biochem canada | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | October 31, 1980 |