CIZ
10 FDA 510(k) clearances · Product code
49 daysmedian time to decision
99 days90th percentile
10clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Androstenedione
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1075
- Medical specialty
- Clinical Chemistry
- Adverse events (MAUDE)
- 2014: 114
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| ACTIVE ANDROSTENEDIONE EIA (K963002) | Diagnostic Systems Laboratories, Inc. | 1996-08-16 |
| COAT-A-COUNT DIRECT ANDROSTENEDIONE (K954755) | Diagnostic Products Corp. | 1995-11-29 |
| ACTIVE ANDROSTANEDIOL GLUCURONIDE (K934751) | Diagnostic Systems Laboratories, Inc. | 1994-01-10 |
| ANDROSTENEDIONE 125I KIT BY RIA (K860559) | Immuchem Corp. | 1986-03-14 |
| DSL ANDROSTENEDIONE RIA (DSL # 4200) (K854673) | Diagnostic Systems Laboratories, Inc. | 1986-01-22 |
| DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) (K854650) | Diagnostic Systems Laboratories, Inc. | 1985-12-13 |
| COAT-A-COUNT ANDROSTENEDIONE RIA KIT (K844398) | Diagnostic Products Corp. | 1984-12-10 |
| ANDROSTENEDIONE BY RIA (K842960) | Radioassay Systems Laboratories, Inc. | 1984-09-27 |
| ANDROSTENEDIONE TEST SET 125I (K832452) | Wien Laboratories, Inc. | 1983-09-12 |
| ANDROSTENEDIONE RADIOIMMUNOASSAY KIT (K801729) | Diagnostics Biochem Canada, Inc. | 1980-10-31 |
Track CIZ automatically
Every clearance here is in the API, with alerts when new ones post.