FDA product code CIA: Methylthymol Blue, Calcium
CIA is the FDA product code for methylthymol blue, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel. FDA has cleared 5 510(k) submissions under CIA, from 5 different applicants. The average 510(k) review took 74 days (median 45).
Classification
| Field | Value |
|---|---|
| Device name | Methylthymol Blue, Calcium |
| Device class | Class II |
| Regulation | 21 CFR 862.1145 |
| 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 CIA clearance
Top CIA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Trace Scientific , Ltd. | 1 | 1987-08-19 |
| J. D. Assoc. | 1 | 1986-09-26 |
| Diagnostic Systems Laboratories, Inc. | 1 | 1982-12-09 |
| Volu Sol Medical Industries | 1 | 1979-12-06 |
| Instrumentation Laboratory CO | 1 | 1977-09-12 |
Most recent CIA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K870369 | Trace Scientific , Ltd. | CALCIUM REAGENT-METHYL THYMOL BLUE METHOD | 1987-08-19 | 203 |
| K863059 | J. D. Assoc. | CALCIOMETER | 1986-09-26 | 45 |
| K822898 | Diagnostic Systems Laboratories, Inc. | DSL 1600 | 1982-12-09 | 71 |
| K792396 | Volu Sol Medical Industries | ELVI CALCIUM | 1979-12-06 | 10 |
| K771468 | Instrumentation Laboratory CO | MULTISTAT III CALCIUM TEST | 1977-09-12 | 39 |
Recalls for CIA devices
openFDA lists no recalls for product code CIA.
Frequently asked questions
What is FDA product code CIA?
CIA is the FDA product code for methylthymol blue, calcium. It is a Class II device, regulated under 21 CFR 862.1145 and reviewed by the Clinical Chemistry panel.
What device class is CIA?
Class II, regulation 21 CFR 862.1145. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIA?
Across 5 cleared submissions the average was 74 days from receipt to decision (median 45).
Which companies have the most CIA clearances?
Trace Scientific , Ltd. (1); J. D. Assoc. (1); Diagnostic Systems Laboratories, Inc. (1); Volu Sol Medical Industries (1); Instrumentation Laboratory CO (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CIA
- Run a recall and safety report across every CIA manufacturer
- Watch product code CIA 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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