FDA product code CIL: Cresol Red Colorimetry, Carbon-Dioxide
CIL is the FDA product code for cresol red colorimetry, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel. FDA has cleared 4 510(k) submissions under CIL, from 3 different applicants. The average 510(k) review took 63 days (median 70).
Classification
| Field | Value |
|---|---|
| Device name | Cresol Red Colorimetry, Carbon-Dioxide |
| Device class | Class II |
| Regulation | 21 CFR 862.1160 |
| 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 CIL clearance
Top CIL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| American Monitor Corp. | 2 | 1983-12-29 |
| Em Diagnostic Systems, Inc. | 1 | 1992-09-09 |
| Boehringer Mannheim Corp. | 1 | 1989-12-19 |
Most recent CIL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K922953 | Em Diagnostic Systems, Inc. | SYSTEMATE CALCIUM TEST TECHNICON RA 1000 | 1992-09-09 | 83 |
| K895880 | Boehringer Mannheim Corp. | PANCREATIC A-AMYLASE EPS | 1989-12-19 | 75 |
| K833724 | American Monitor Corp. | ENZYMATIC CO2 | 1983-12-29 | 66 |
| K800111 | American Monitor Corp. | CO2 CONTENT | 1980-02-13 | 28 |
Recalls for CIL devices
openFDA lists no recalls for product code CIL.
Frequently asked questions
What is FDA product code CIL?
CIL is the FDA product code for cresol red colorimetry, carbon-dioxide. It is a Class II device, regulated under 21 CFR 862.1160 and reviewed by the Clinical Chemistry panel.
What device class is CIL?
Class II, regulation 21 CFR 862.1160. Typical premarket route: 510(k).
How long does a 510(k) take for product code CIL?
Across 4 cleared submissions the average was 63 days from receipt to decision (median 70).
Which companies have the most CIL clearances?
American Monitor Corp. (2); Em Diagnostic Systems, Inc. (1); Boehringer Mannheim Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CIL
- Run a recall and safety report across every CIL manufacturer
- Watch product code CIL 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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