Panels › Clinical Toxicology › Product code LCQ · Class 2
Fluorescent Immunoassay Gentamicin
Regulation 862.3450
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
Top companies in LCQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Diagnostic International, Ltd. | 0 | 2 |
| Abbott Laboratories | 2 | 0 |
| Roche Diagnostic Systems, Inc. | 2 | 0 |
| American Diagnostic Corp. | 1 | 0 |
| Bio-Rad | 1 | 0 |
| Bioprobe Intl., Inc. | 1 | 0 |
| Colony Laboratories, Inc. | 1 | 0 |
| ConvaTec, Inc | 0 | 1 |
| Hospitax | 1 | 0 |
| Innotron Diagnostics | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 6, 1997 | K972609 | VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM Bio-Rad | LCQ |
| Feb 9, 1996 | K955569 | INNOFLUOR GENTAMICIN ASSAY SYSTEM Oxis Intl., Inc. | LCQ |
| Mar 9, 1995 | K945523 | COBAS(R)-FP REAGENTS FOR GENTAMICIN AND COBAS(R)-FP GENTAMICIN CALIBRATORS Roche Diagnostic Systems, Inc. | LCQ |
| Nov 17, 1994 | K943550 | GENTAMICIN FPIA REAGENT SET AND CALIBRATORS Sigma Diagnostics, Inc. | LCQ |
| Feb 21, 1991 | K905721 | OPUS GENTAMICIN Pb Diagnostic Systems, Inc. | LCQ |
| Oct 29, 1990 | K904226 | 'TDXFLX ANALYZER Abbott Laboratories | LCQ |
| Sep 28, 1989 | K894523 | FPR GENTAMICIN KIT Colony Laboratories, Inc. | LCQ |
| Jun 25, 1985 | K852158 | BIOPROBE FLUOR GENTAMICIN IN SERUM OR PLASMA Bioprobe Intl., Inc. | LCQ |
| Jun 10, 1985 | K852013 | GENTAMICIN KIT(FPIA) Windsor Laboratories, Inc. | LCQ |
| Feb 1, 1985 | K843827 | COBAS REAGENTS FOR GENTAMICIN & CALIBRAT Roche Diagnostic Systems, Inc. | LCQ |
| May 31, 1984 | K841865 | INNOFLOUR GENTAMICIN Innotron Diagnostics | LCQ |
| May 2, 1984 | K841162 | IMMPULSE GENTAMICIN ASSAY REAGENTS Paragon Diagnostics, Inc. | LCQ |
| Feb 18, 1982 | K820285 | SYVA ADVANCE SYST. EMIT-AMD GENT. ASSAY Syva Co. | LCQ |
| Dec 31, 1981 | K813539 | GENTAMICIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp. | LCQ |
| Apr 17, 1981 | K810942 | AMES TDA GENTAMICIN TEST Miles Laboratories, Inc. | LCQ |
| Aug 20, 1980 | K801867 | DISPOSABLE MEDICATION NEBULIZER Hospitax | LCQ |
| May 23, 1980 | K801084 | CYBREX GENTAMICIN Abbott Laboratories | LCQ |
| Jan 23, 1980 | K800032 | FIAX TEST KIT FOR GENTAMICIN QUAN. Intl. Diagnostic Technology | LCQ |
| Jan 26, 1979 | K782025 | GENTAMICIN FLUROIMMUNASSAY KIT Technia Diagnostics , Ltd. | LCQ |
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