JTWClass I
System, Transport, Aerobic
21 CFR 866.2900 / Microbiology
JTW is the FDA product code for System, Transport, Aerobic, a class I device type, regulated under 21 CFR 866.2900. As of , FDA records hold 43 510(k) clearances under this code, the most recent dated , and 8 recalls.
Classification record
- Product code
- JTW
- Device name
- System, Transport, Aerobic
- Regulation
- 21 CFR 866.2900
- Device class
- Class I
- Review panel
- Microbiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 43
- Ingested recalls
- 8
Clearances, product code JTW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 9 |
| 1978 | 1 |
| 1979 | 3 |
| 1980 | 2 |
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 7 |
| 1987 | 2 |
| 1988 | 1 |
| 1989 | 1 |
| 1990 | 1 |
| 1994 | 1 |
| 1996 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2002 | 2 |
| 2006 | 1 |
| 2012 | 1 |
Applicants with the most clearances
Product code JTW| Applicant | Clearances |
|---|---|
| Precision Dynamics Corporation | 9 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 5 |
| Difco Laboratories, Inc. | 3 |
| Preventive Diagnostics Corp. | 3 |
| Biolog, Inc. | 2 |
| COPAN Diagnostics, Inc. | 2 |
| Gibco Laboratories Life Technologies, Inc. | 2 |
| Marion Laboratories, Inc. | 2 |
| Spectrum Diagnostic, Inc. | 2 |
| Technology Management & Marketing, Inc. | 2 |
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.
