JTTClass II
Susceptibility Test Powders, Antimicrobial
21 CFR 866.1640 / Microbiology
JTT is the FDA product code for Susceptibility Test Powders, Antimicrobial, a class II device type, regulated under 21 CFR 866.1640. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- JTT
- Device name
- Susceptibility Test Powders, Antimicrobial
- Regulation
- 21 CFR 866.1640
- 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
- 14
- Ingested recalls
- 1
Clearances, product code JTT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1982 | 3 |
| 1983 | 1 |
| 1986 | 5 |
| 1987 | 1 |
| 1988 | 1 |
| 1989 | 1 |
| 1994 | 1 |
| 1998 | 1 |
Applicants with the most clearances
Product code JTT| Applicant | Clearances |
|---|---|
| BD Becton Dickinson Vacutainer Systems Preanalytic | 3 |
| Merck, Sharp & Dohme | 3 |
| Miles Pharmaceuticals | 2 |
| Accumed Intl., Inc. | 1 |
| Difco Laboratories, Inc. | 1 |
| Lilly Research Laboratories | 1 |
| Miles Laboratories, Inc. | 1 |
| bioMerieux, Inc. | 1 |
| Pasco Laboratories, 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.
