Product code CIZ— Clinical Chemistry
ACTIVE ANDROSTANEDIOL GLUCURONIDE
- Classification name
- Radioimmunoassay, Androstenedione
- Device class
- Class 1
- Regulation
- 21 CFR 862.1075
- Advisory panel
- Clinical Chemistry
- Total cleared
- 10
- First cleared
- Most recent
Market context for product code CIZ
FDA has cleared devices under product code CIZ between 1980 and 1996, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1996
- 1995
- 1994
- 1986
- 1985
- 1984
- 1983
- 1980
Top applicants under product code CIZ
Recent clearances under product code CIZ
- K963002 — ACTIVE ANDROSTENEDIONE EIA
- K954755 — COAT-A-COUNT DIRECT ANDROSTENEDIONE
- K934751 — ACTIVE ANDROSTANEDIOL GLUCURONIDE
- K860559 — ANDROSTENEDIONE 125I KIT BY RIA
- K854673 — DSL ANDROSTENEDIONE RIA (DSL # 4200)
- K854650 — DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
- K844398 — COAT-A-COUNT ANDROSTENEDIONE RIA KIT
- K842960 — ANDROSTENEDIONE BY RIA
- K832452 — ANDROSTENEDIONE TEST SET 125I
- K801729 — ANDROSTENEDIONE RADIOIMMUNOASSAY KIT
Data sourced from openFDA. This site is unofficial and independent of the FDA.