Phenolphthalein Colorimetry, Carbon-Dioxide
The Phenolphthalein Colorimetry Carbon Dioxide test is an in vitro diagnostic assay used in clinical chemistry laboratories to measure total carbon dioxide or bicarbonate concentrations in blood or serum, providing information relevant to acid-base balance assessment. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket clearance. The product code is KMS and it is regulated under 21 CFR 862.1160 in the Clinical Chemistry specialty. This device is eligible for third-party review.
Research product code KMS in seconds
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Basic Information
- Product Code
- KMS
- 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 5 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K872886 | CARBON DIOXIDE | Aug 13, 1987 | Substantially Equivalent | Catachem, Inc. |
| K870025 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | Mar 13, 1987 | Substantially Equivalent | American Research Products Co. |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Oct 10, 1980 | Substantially Equivalent | Panmed, Inc. |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | May 30, 1980 | Substantially Equivalent | Diagnostic Solutions, Inc. |
| K780506 | CARBON DIOXIDE REAGENTS | May 03, 1978 | Substantially Equivalent | Gamma Enterprises, Inc. |