FDA Product Code
FDA Product Code CIZ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1075
510(k) Clearances — 10 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K963002 | ACTIVE ANDROSTENEDIONE EIA | Diagnostic Systems Laboratories, Inc. | 1996-08-16 | Traditional | PDF ↗ |
| K954755 | COAT-A-COUNT DIRECT ANDROSTENEDIONE | Diagnostic Products Corp. | 1995-11-29 | Traditional | PDF ↗ |
| K934751 | ACTIVE ANDROSTANEDIOL GLUCURONIDE | Diagnostic Systems Laboratories, Inc. | 1994-01-10 | Traditional | PDF ↗ |
| K860559 | ANDROSTENEDIONE 125I KIT BY RIA | Immuchem Corp. | 1986-03-14 | Traditional | PDF ↗ |
| K854673 | DSL ANDROSTENEDIONE RIA (DSL # 4200) | Diagnostic Systems Laboratories, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K854650 | DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800) | Diagnostic Systems Laboratories, Inc. | 1985-12-13 | Traditional | PDF ↗ |
| K844398 | COAT-A-COUNT ANDROSTENEDIONE RIA KIT | Diagnostic Products Corp. | 1984-12-10 | Traditional | PDF ↗ |
| K842960 | ANDROSTENEDIONE BY RIA | Radioassay Systems Laboratories, Inc. | 1984-09-27 | Traditional | PDF ↗ |
| K832452 | ANDROSTENEDIONE TEST SET 125I | Wien Laboratories, Inc. | 1983-09-12 | Traditional | PDF ↗ |
| K801729 | ANDROSTENEDIONE RADIOIMMUNOASSAY KIT | Diagnostics Biochem Canada, Inc. | 1980-10-31 | Traditional | PDF ↗ |
Product code CIZ · Class I · Clinical Chemistry. Data: openFDA.