CENClass I
Dye-Indicator, Ph (Urinary, Non-Quantitative)
21 CFR 862.1550 / Clinical Chemistry
CEN is the FDA product code for Dye-Indicator, Ph (Urinary, Non-Quantitative), a class I device type, regulated under 21 CFR 862.1550. As of , FDA records hold 11 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- CEN
- Device name
- Dye-Indicator, Ph (Urinary, Non-Quantitative)
- Regulation
- 21 CFR 862.1550
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 11
- Ingested recalls
- 5
Clearances, product code CEN
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 3 |
| 1984 | 1 |
| 1997 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2009 | 1 |
Applicants with the most clearances
Product code CEN| Applicant | Clearances |
|---|---|
| Common Sense, Ltd. | 2 |
| Abbott Medical | 1 |
| Germaine Laboratories, Inc. | 1 |
| Helena Laboratories, Corp. | 1 |
| Kyoto Diagnostics, Inc. | 1 |
| Lenal Creative Approaches, Inc. | 1 |
| Litmus Concepts, Inc. | 1 |
| Ortho-Clinical Diagnostics, Inc. | 1 |
| Syn-Kit, Inc. | 1 |
| Uridynamics, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.