KMSClass II
Phenolphthalein Colorimetry, Carbon-Dioxide
21 CFR 862.1160 / Clinical Chemistry
KMS is the FDA product code for Phenolphthalein Colorimetry, Carbon-Dioxide, a class II device type, regulated under 21 CFR 862.1160. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- KMS
- Device name
- Phenolphthalein Colorimetry, Carbon-Dioxide
- Regulation
- 21 CFR 862.1160
- Device class
- Class II
- Review panel
- Clinical Chemistry
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 5
- Ingested recalls
- 0
Clearances, product code KMS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1980 | 2 |
| 1987 | 2 |
Applicants with the most clearances
Product code KMS| Applicant | Clearances |
|---|---|
| American Research Products Co. | 1 |
| Catachem, Inc. | 1 |
| Diagnostic Solutions, Inc. | 1 |
| Gamma Enterprises, Inc. | 1 |
| Panmed, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeNo registered establishment in MDM’s records lists product code KMS.
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