FDA product code CIQ: Diazo, Ast/Sgot
CIQ is the FDA product code for diazo, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel. FDA has cleared 7 510(k) submissions under CIQ, from 7 different applicants. The average 510(k) review took 48 days (median 50). FDA has posted 1 recall for CIQ devices.
Classification
| Field | Value |
|---|---|
| Device name | Diazo, Ast/Sgot |
| Device class | Class II |
| Regulation | 21 CFR 862.1100 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) exempt |
Top CIQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tech-Co, Inc. | 1 | 1988-06-07 |
| Sterling Diagnostics, Inc. | 1 | 1986-04-03 |
| Technostics Intl. | 1 | 1986-01-14 |
| Livonia Diagnostics, Inc. | 1 | 1984-11-27 |
| Medical Specialties, Inc. | 1 | 1984-05-01 |
2 more applicants have CIQ clearances. See the full list in Caduvo.
Most recent CIQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K881173 | Tech-Co, Inc. | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | 1988-06-07 | 81 |
| K860216 | Sterling Diagnostics, Inc. | SGOT (AST) REAGENT SET | 1986-04-03 | 71 |
| K855189 | Technostics Intl. | GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET | 1986-01-14 | 19 |
| K844322 | Livonia Diagnostics, Inc. | SGOT REAGENT SET | 1984-11-27 | 20 |
| K841065 | Medical Specialties, Inc. | SGOT REAGENT SET | 1984-05-01 | 50 |
Recalls for CIQ devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-07-20.
Frequently asked questions
What is FDA product code CIQ?
CIQ is the FDA product code for diazo, ast/sgot. It is a Class II device, regulated under 21 CFR 862.1100 and reviewed by the Clinical Chemistry panel.
What device class is CIQ?
Class II, regulation 21 CFR 862.1100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code CIQ?
Across 7 cleared submissions the average was 48 days from receipt to decision (median 50).
Which companies have the most CIQ clearances?
Tech-Co, Inc. (1); Sterling Diagnostics, Inc. (1); Technostics Intl. (1); Livonia Diagnostics, Inc. (1); Medical Specialties, Inc. (1).
Have CIQ devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-07-20.
Next steps
- Run an FDA pathway report with predicate devices for product code CIQ
- Run a recall and safety report across every CIQ manufacturer
- Watch product code CIQ 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.
All Clinical Chemistry product codes · FDA product code lookup