FDA product code JWT: Antigen, Cf, Aspergillus Spp.
JWT is the FDA product code for antigen, cf, aspergillus spp.. It is a Class I device, regulated under 21 CFR 866.3040 and reviewed by the Microbiology panel. FDA has cleared 5 510(k) submissions under JWT, from 5 different applicants. The average 510(k) review took 30 days (median 21).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, Aspergillus Spp. |
| Device class | Class I |
| Regulation | 21 CFR 866.3040 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JWT clearance
Top JWT applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Nolan Biological Laboratories, Inc. | 1 | 1981-10-20 |
| Meridian Diagnostics, Inc. | 1 | 1980-01-17 |
| Immuno-Mycologics, Inc. | 1 | 1979-08-16 |
| Diagnostica, Inc. | 1 | 1979-05-31 |
| I M, Inc. | 1 | 1976-11-01 |
Most recent JWT clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K812740 | Nolan Biological Laboratories, Inc. | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | 1981-10-20 | 21 |
| K792700 | Meridian Diagnostics, Inc. | ASPERGILLUS SP, COMPLEMENT FIXATION | 1980-01-17 | 21 |
| K791387 | Immuno-Mycologics, Inc. | ASPERGILLUS MYCELIAL ANTIGEN #CF10024X | 1979-08-16 | 36 |
| K790672 | Diagnostica, Inc. | ASPERGILLUS FUMIGATUS, ASPERGILLUS FLAVU | 1979-05-31 | 55 |
| K760830 | I M, Inc. | ASPERGILLUS MYCELIAL ANTIGEN | 1976-11-01 | 19 |
Recalls for JWT devices
openFDA lists no recalls for product code JWT.
Frequently asked questions
What is FDA product code JWT?
JWT is the FDA product code for antigen, cf, aspergillus spp.. It is a Class I device, regulated under 21 CFR 866.3040 and reviewed by the Microbiology panel.
What device class is JWT?
Class I, regulation 21 CFR 866.3040. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JWT?
Across 5 cleared submissions the average was 30 days from receipt to decision (median 21).
Which companies have the most JWT clearances?
Nolan Biological Laboratories, Inc. (1); Meridian Diagnostics, Inc. (1); Immuno-Mycologics, Inc. (1); Diagnostica, Inc. (1); I M, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JWT
- Run a recall and safety report across every JWT manufacturer
- Watch product code JWT 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.
All Microbiology product codes · FDA product code lookup · 510(k) database search · 510(k) review times