FDA product code CIO: Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
CIO is the FDA product code for thymolphthalein monophosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel. FDA has cleared 11 510(k) submissions under CIO, from 11 different applicants. The average 510(k) review took 38 days (median 31).
Classification
| Field | Value |
|---|---|
| Device name | Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes |
| Device class | Class II |
| Regulation | 21 CFR 862.1050 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CIO clearance
Top CIO applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tech-Co, Inc. | 1 | 1988-04-05 |
| Sterling Diagnostics, Inc. | 1 | 1986-02-11 |
| Technostics Intl. | 1 | 1986-01-14 |
| Sandare Chemical Co., Inc. | 1 | 1984-12-10 |
| Livonia Diagnostics, Inc. | 1 | 1984-11-20 |
6 more applicants have CIO clearances. See the full list in Caduvo.
Most recent CIO clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K880177 | Tech-Co, Inc. | ALKALINE PHOSPHATASE, THYMOLPHTHALEIN MONOPHOSPHAT | 1988-04-05 | 81 |
| K860351 | Sterling Diagnostics, Inc. | ALKALINE PHOSPHATASE REAGENT SET | 1986-02-11 | 12 |
| K855192 | Technostics Intl. | ALKALINE PHOSPHATASE REAGENT SET | 1986-01-14 | 19 |
| K844498 | Sandare Chemical Co., Inc. | SANDARE ALKALINE PHOSPHATASE PROCEDURE | 1984-12-10 | 20 |
| K844237 | Livonia Diagnostics, Inc. | ALKALINE PHOSPHATASE REAGENT SET | 1984-11-20 | 19 |
Recalls for CIO devices
openFDA lists no recalls for product code CIO.
Frequently asked questions
What is FDA product code CIO?
CIO is the FDA product code for thymolphthalein monophosphate, alkaline phosphatase or isoenzymes. It is a Class II device, regulated under 21 CFR 862.1050 and reviewed by the Clinical Chemistry panel.
What device class is CIO?
Class II, regulation 21 CFR 862.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIO?
Across 11 cleared submissions the average was 38 days from receipt to decision (median 31).
Which companies have the most CIO clearances?
Tech-Co, Inc. (1); Sterling Diagnostics, Inc. (1); Technostics Intl. (1); Sandare Chemical Co., Inc. (1); Livonia Diagnostics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CIO
- Run a recall and safety report across every CIO manufacturer
- Watch product code CIO 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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