JXAClass I
Kit, Screening, Urine
21 CFR 866.2660 / Microbiology
JXA is the FDA product code for Kit, Screening, Urine, a class I device type, regulated under 21 CFR 866.2660. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JXA
- Device name
- Kit, Screening, Urine
- Regulation
- 21 CFR 866.2660
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 44
- Ingested recalls
- 0
Clearances, product code JXA
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 5 |
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 1 |
| 1983 | 4 |
| 1984 | 3 |
| 1985 | 1 |
| 1986 | 4 |
| 1987 | 4 |
| 1988 | 3 |
| 1989 | 2 |
| 1990 | 1 |
| 1991 | 1 |
| 1992 | 1 |
| 1993 | 1 |
| 1994 | 1 |
| 1995 | 4 |
| 1998 | 2 |
| 2001 | 1 |
Applicants with the most clearances
Product code JXA| Applicant | Clearances |
|---|---|
| Clinical Convenience Products, Inc. | 4 |
| Applied Polytechnology, Inc. | 3 |
| Izon Business Products, Inc. | 3 |
| Los Alamos Diagnostics | 3 |
| Marion Laboratories, Inc. | 2 |
| Abbott Medical | 1 |
| Analytical Luminescence Laboratory, Inc. | 1 |
| Bioclinical Systems, Inc. | 1 |
| Biomerieux Vitek, Inc. | 1 |
| Biotron, Ltd. | 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.