JFPClass II
Electrode, Ion Specific, Calcium
21 CFR 862.1145 / Clinical Chemistry
JFP is the FDA product code for Electrode, Ion Specific, Calcium, a class II device type, regulated under 21 CFR 862.1145. As of , FDA records hold 29 510(k) clearances under this code, the most recent dated , and 5 recalls.
Classification record
- Product code
- JFP
- Device name
- Electrode, Ion Specific, Calcium
- Regulation
- 21 CFR 862.1145
- 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
- 29
- Ingested recalls
- 5
Clearances, product code JFP
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1980 | 1 |
| 1981 | 2 |
| 1983 | 3 |
| 1985 | 1 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 3 |
| 1990 | 2 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 1 |
| 1996 | 3 |
| 1997 | 1 |
| 1998 | 1 |
| 2016 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2023 | 1 |
Applicants with the most clearances
Product code JFP| Applicant | Clearances |
|---|---|
| Nova Biomedical Corporation | 6 |
| Avl Scientific Corp. | 4 |
| Medica Corp. | 3 |
| Abbott Medical | 2 |
| Amdev, Inc. | 2 |
| Ionetics, Inc. | 2 |
| Alko Diagnostic Corp. | 1 |
| Applied Medical Technologies | 1 |
| Corning Medical & Scientific | 1 |
| Eos Technology Corp. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this code- Abbott Medical
- Abbott Point of Care Canada Limited
- Beckman Coulter Ireland Inc
- Bionostics, Inc.
- Carolina Liquid Chemistries
- Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti
- DIAMOND DIAGNOSTICS Inc
- Edan Instruments, Inc.
- Epocal Inc
- Fisher Diagnostics
- Instrumentation Laboratory Co.
- INSTRUMENTATION LABORATORY CO. - Devens
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
