FDA product code JWW: Antigen, Cf, B. Dermatitidis
JWW is the FDA product code for antigen, cf, b. dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel. FDA has cleared 3 510(k) submissions under JWW, from 2 different applicants. The average 510(k) review took 34 days (median 27).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Cf, B. Dermatitidis |
| Device class | Class II |
| Regulation | 21 CFR 866.3060 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every JWW clearance
Top JWW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Meridian Diagnostics, Inc. | 2 | 1980-01-23 |
| Nolan Biological Laboratories, Inc. | 1 | 1980-09-26 |
Most recent JWW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K802128 | Nolan Biological Laboratories, Inc. | IMMUNODIFFUSSION REAGENTS/SEROLOGICAL | 1980-09-26 | 53 |
| K792683 | Meridian Diagnostics, Inc. | BLASTOMYCES/ANTIGEN FOR IMMUNODIFUSION | 1980-01-23 | 27 |
| K792680 | Meridian Diagnostics, Inc. | BLASTOMYCES DERMATITIDIS, ANTIGEN | 1980-01-17 | 21 |
Recalls for JWW devices
openFDA lists no recalls for product code JWW.
Frequently asked questions
What is FDA product code JWW?
JWW is the FDA product code for antigen, cf, b. dermatitidis. It is a Class II device, regulated under 21 CFR 866.3060 and reviewed by the Microbiology panel.
What device class is JWW?
Class II, regulation 21 CFR 866.3060. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JWW?
Across 3 cleared submissions the average was 34 days from receipt to decision (median 27).
Which companies have the most JWW clearances?
Meridian Diagnostics, Inc. (2); Nolan Biological Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JWW
- Run a recall and safety report across every JWW manufacturer
- Watch product code JWW 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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