Panels › Microbiology › Product code JWL · Class 2
Antigen, Treponema Pallidum For Fta-Abs Test
Regulation 866.3830
0510(k)s in 12 months (4 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JWL
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioware Products | 1 | 0 |
| Immuno-Diagnostic Products, Inc. | 1 | 0 |
| Miles Laboratories, Inc. | 1 | 0 |
| Parasitic Disease Consultants | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 26, 1983 | K831296 | POLYCHACO FIA-ABS TEST FOR SYPHILIS Parasitic Disease Consultants | JWL |
| Oct 23, 1980 | K802276 | FTA-ABS BIOPAK Bioware Products | JWL |
| Oct 23, 1980 | K801959 | FTA-ABS TEST Immuno-Diagnostic Products, Inc. | JWL |
| Aug 20, 1980 | K801928 | LAB-TEK FTA-ABS KIT Miles Laboratories, Inc. | JWL |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.