Cresol Red Colorimetry, Carbon-Dioxide
The Cresol Red Colorimetry, Carbon Dioxide test system (product code CIL) is an in-vitro diagnostic device used in clinical chemistry to measure carbon dioxide or bicarbonate concentrations in serum or plasma using a cresol red indicator-based colorimetric method, supporting electrolyte and acid-base assessment. It is classified as FDA Class 2, indicating moderate risk, and requires a 510(k) premarket notification. It falls under regulation 21 CFR 862.1160 in the Clinical Chemistry medical specialty. This device is eligible for third-party review under the FDA's accredited persons program.
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Basic Information
- Product Code
- CIL
- Device Class
- FDA class 2
- Regulation Number
- 862.1160
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K922953 | SYSTEMATE CALCIUM TEST TECHNICON RA 1000 | Sep 09, 1992 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K895880 | PANCREATIC A-AMYLASE EPS | Dec 19, 1989 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K833724 | ENZYMATIC CO2 | Dec 29, 1983 | Substantially Equivalent | American Monitor Corp. |
| K800111 | CO2 CONTENT | Feb 13, 1980 | Substantially Equivalent | American Monitor Corp. |