FDA product code JWL: Antigen, Treponema Pallidum For Fta-Abs Test
JWL is the FDA product code for antigen, treponema pallidum for fta-abs test. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under JWL, from 4 different applicants. The average 510(k) review took 51 days (median 50).
Classification
| Field | Value |
|---|---|
| Device name | Antigen, Treponema Pallidum For Fta-Abs Test |
| Device class | Class II |
| Regulation | 21 CFR 866.3830 |
| 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 JWL clearance
Top JWL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Parasitic Disease Consultants | 1 | 1983-07-26 |
| Bioware Products | 1 | 1980-10-23 |
| Immuno-Diagnostic Products, Inc. | 1 | 1980-10-23 |
| Miles Laboratories, Inc. | 1 | 1980-08-20 |
Most recent JWL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K831296 | Parasitic Disease Consultants | POLYCHACO FIA-ABS TEST FOR SYPHILIS | 1983-07-26 | 97 |
| K802276 | Bioware Products | FTA-ABS BIOPAK | 1980-10-23 | 35 |
| K801959 | Immuno-Diagnostic Products, Inc. | FTA-ABS TEST | 1980-10-23 | 65 |
| K801928 | Miles Laboratories, Inc. | LAB-TEK FTA-ABS KIT | 1980-08-20 | 8 |
Recalls for JWL devices
openFDA lists no recalls for product code JWL.
Frequently asked questions
What is FDA product code JWL?
JWL is the FDA product code for antigen, treponema pallidum for fta-abs test. It is a Class II device, regulated under 21 CFR 866.3830 and reviewed by the Microbiology panel.
What device class is JWL?
Class II, regulation 21 CFR 866.3830. Typical premarket route: 510(k).
How long does a 510(k) take for product code JWL?
Across 4 cleared submissions the average was 51 days from receipt to decision (median 50).
Which companies have the most JWL clearances?
Parasitic Disease Consultants (1); Bioware Products (1); Immuno-Diagnostic Products, Inc. (1); Miles Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code JWL
- Run a recall and safety report across every JWL manufacturer
- Watch product code JWL 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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