JREClass I
Refractometer For Clinical Use
21 CFR 862.2800 / Clinical Chemistry
JRE is the FDA product code for Refractometer For Clinical Use, a class I device type, regulated under 21 CFR 862.2800. As of , FDA records hold 13 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JRE
- Device name
- Refractometer For Clinical Use
- Regulation
- 21 CFR 862.2800
- 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
- 13
- Ingested recalls
- 0
Clearances, product code JRE
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 1 |
| 1983 | 1 |
| 1984 | 1 |
| 1990 | 1 |
| 1994 | 3 |
| 1995 | 3 |
| 1996 | 1 |
Applicants with the most clearances
Product code JRE| Applicant | Clearances |
|---|---|
| Vee Gee Scientific, Inc. | 6 |
| Biovation, Inc. | 1 |
| Gyrus ACMI, Inc. | 1 |
| Iris | 1 |
| Kyoto Diagnostics, Inc. | 1 |
| Miles Laboratories, Inc. | 1 |
| Nippon Kogaku, Inc. | 1 |
| Teco Diagnostics | 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.