JWL
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Antigen, Treponema Pallidum For Fta-Abs Test
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3830
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Download CSV table Client report (share link) ◉ Watch
Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.
Building a predicate table? Click + Add on candidates below (up to 8), then compare and export from your Builder.
| Record | Firm | Date | Builder |
|---|---|---|---|
| POLYCHACO FIA-ABS TEST FOR SYPHILIS (K831296) | Parasitic Disease Consultants | 1983-07-26 | + Add |
| FTA-ABS BIOPAK (K802276) | Bioware Products | 1980-10-23 | + Add |
| FTA-ABS TEST (K801959) | Immuno-Diagnostic Products, Inc. | 1980-10-23 | + Add |
| LAB-TEK FTA-ABS KIT (K801928) | Miles Laboratories, Inc. | 1980-08-20 | + Add |
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Every clearance here is in the API, with alerts when new ones post.