FDA product code JTX: Transport Systems, Anaerobic
JTX is the FDA product code for transport systems, anaerobic. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel. FDA has cleared 8 510(k) submissions under JTX, from 8 different applicants. The average 510(k) review took 57 days (median 42).
Classification
| Field | Value |
|---|---|
| Device name | Transport Systems, Anaerobic |
| Device class | Class I |
| Regulation | 21 CFR 866.2900 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every JTX clearance
Top JTX applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Medical Laboratory Automation Systems, Inc. | 1 | 1990-07-16 |
| Acuson Corp. | 1 | 1990-07-03 |
| Accu-Med Corp. | 1 | 1988-07-06 |
| Marion Laboratories, Inc. | 1 | 1979-10-17 |
| American Monitor Corp. | 1 | 1978-09-14 |
3 more applicants have JTX clearances. See the full list in Caduvo.
Most recent JTX clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K901645 | Medical Laboratory Automation Systems, Inc. | ANAEROBIC ACCU-CULSHURE(TM) | 1990-07-16 | 98 |
| K897151 | Acuson Corp. | ACUSON V328 AND C5432 TRANSDUCERS | 1990-07-03 | 189 |
| K882637 | Accu-Med Corp. | ACCU-CULSHURE TM | 1988-07-06 | 9 |
| K791724 | Marion Laboratories, Inc. | BIO-BAG ENVIRONMENTAL CHAMBER (A & B) | 1979-10-17 | 48 |
| K781376 | American Monitor Corp. | STANDARDIZE TGCL & TGCH | 1978-09-14 | 36 |
Recalls for JTX devices
openFDA lists no recalls for product code JTX.
Frequently asked questions
What is FDA product code JTX?
JTX is the FDA product code for transport systems, anaerobic. It is a Class I device, regulated under 21 CFR 866.2900 and reviewed by the Microbiology panel.
What device class is JTX?
Class I, regulation 21 CFR 866.2900. Typical premarket route: 510(k).
How long does a 510(k) take for product code JTX?
Across 8 cleared submissions the average was 57 days from receipt to decision (median 42).
Which companies have the most JTX clearances?
Medical Laboratory Automation Systems, Inc. (1); Acuson Corp. (1); Accu-Med Corp. (1); Marion Laboratories, Inc. (1); American Monitor Corp. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JTX
- Run a recall and safety report across every JTX manufacturer
- Watch product code JTX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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