Panels › Clinical Toxicology › Product code LGJ · Class 2
Fluorescence Polarization Immunoassay, Amibacin
Regulation 862.3035
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LGJ
| Company | 510(k)s | Recalls |
|---|---|---|
| Roche Diagnostic Systems, Inc. | 1 | 0 |
| Roche Diagnostics Corp. | 1 | 0 |
| Windsor Laboratories, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 22, 1999 | K991597 | COBAS INTEGRA AMIKACIN MAB Roche Diagnostics Corp. | LGJ |
| Jun 13, 1994 | K941712 | COBAS-FP REAGENTS AND CALIBRATORS Roche Diagnostic Systems, Inc. | LGJ |
| Aug 4, 1986 | K862248 | AMIKACIN KIT (FPIA) Windsor Laboratories, Inc. | LGJ |
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