FDA product code CIZ: Radioimmunoassay, Androstenedione
CIZ is the FDA product code for radioimmunoassay, androstenedione. It is a Class I device, regulated under 21 CFR 862.1075 and reviewed by the Clinical Chemistry panel. FDA has cleared 10 510(k) submissions under CIZ, from 6 different applicants. The average 510(k) review took 51 days (median 46). FDA has posted 5 recalls for CIZ devices.
Classification
| Field | Value |
|---|---|
| Device name | Radioimmunoassay, Androstenedione |
| Device class | Class I |
| Regulation | 21 CFR 862.1075 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every CIZ clearance
Top CIZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Diagnostic Systems Laboratories, Inc. | 4 | 1996-08-16 |
| Diagnostic Products Corp. | 2 | 1995-11-29 |
| Immuchem Corp. | 1 | 1986-03-14 |
| Radioassay Systems Laboratories, Inc. | 1 | 1984-09-27 |
| Wien Laboratories, Inc. | 1 | 1983-09-12 |
1 more applicants have CIZ clearances. See the full list in Caduvo.
Most recent CIZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K963002 | Diagnostic Systems Laboratories, Inc. | ACTIVE ANDROSTENEDIONE EIA | 1996-08-16 | 14 |
| K954755 | Diagnostic Products Corp. | COAT-A-COUNT DIRECT ANDROSTENEDIONE | 1995-11-29 | 44 |
| K934751 | Diagnostic Systems Laboratories, Inc. | ACTIVE ANDROSTANEDIOL GLUCURONIDE | 1994-01-10 | 98 |
| K860559 | Immuchem Corp. | ANDROSTENEDIONE 125I KIT BY RIA | 1986-03-14 | 28 |
| K854673 | Diagnostic Systems Laboratories, Inc. | DSL ANDROSTENEDIONE RIA (DSL # 4200) | 1986-01-22 | 62 |
Recalls for CIZ devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2014-06-09.
Frequently asked questions
What is FDA product code CIZ?
CIZ is the FDA product code for radioimmunoassay, androstenedione. It is a Class I device, regulated under 21 CFR 862.1075 and reviewed by the Clinical Chemistry panel.
What device class is CIZ?
Class I, regulation 21 CFR 862.1075. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CIZ?
Across 10 cleared submissions the average was 51 days from receipt to decision (median 46).
Which companies have the most CIZ clearances?
Diagnostic Systems Laboratories, Inc. (4); Diagnostic Products Corp. (2); Immuchem Corp. (1); Radioassay Systems Laboratories, Inc. (1); Wien Laboratories, Inc. (1).
Have CIZ devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2014-06-09.
Next steps
- Run an FDA pathway report with predicate devices for product code CIZ
- Run a recall and safety report across every CIZ manufacturer
- Watch product code CIZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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