JTYClass II
Culture Media, For Isolation Of Pathogenic Neisseria
21 CFR 866.2410 / Microbiology
JTY is the FDA product code for Culture Media, For Isolation Of Pathogenic Neisseria, a class II device type, regulated under 21 CFR 866.2410. As of , FDA records hold 83 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- JTY
- Device name
- Culture Media, For Isolation Of Pathogenic Neisseria
- Regulation
- 21 CFR 866.2410
- Device class
- Class II
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 83
- Ingested recalls
- 9
Clearances, product code JTY
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 6 |
| 1977 | 9 |
| 1978 | 1 |
| 1979 | 10 |
| 1980 | 3 |
| 1981 | 8 |
| 1982 | 5 |
| 1983 | 9 |
| 1984 | 8 |
| 1985 | 7 |
| 1986 | 2 |
| 1987 | 4 |
| 1988 | 2 |
| 1993 | 3 |
| 1994 | 2 |
| 1995 | 1 |
| 1996 | 1 |
| 1999 | 1 |
| 2021 | 1 |
Applicants with the most clearances
Product code JTY| Applicant | Clearances |
|---|---|
| Granite Diagnostics, Inc. | 6 |
| Gibco Laboratories Life Technologies, Inc. | 5 |
| Isle Media and Sterile Products, Inc. | 5 |
| Otisville Biotech, Inc. | 5 |
| Flow Laboratories, Inc. | 4 |
| Neogen Culture Media | 3 |
| American Laboratory Supply, Inc. | 3 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 3 |
| Bioclinical Systems, Inc. | 3 |
| Biomedia, Inc. | 3 |
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.
