Panels › Clinical Toxicology › Product code LGI · Class 2
Fluorescence Polarization Immunoassay, Carbamazepine
Regulation 862.3645
0510(k)s in 12 months (3 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in LGI
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Diagnostic International, Ltd. | 0 | 4 |
| Abbott Laboratories | 1 | 0 |
| Innotron of Oregon, Inc. | 1 | 0 |
| Sigma Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 10, 1994 | K944063 | FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINE Sigma Diagnostics, Inc. | LGI |
| Jun 21, 1994 | K940682 | AXSYM(TM) QUINIDINE Abbott Laboratories | LGI |
| Apr 12, 1990 | K900702 | MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA Innotron of Oregon, Inc. | LGI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.