Panels › Clinical Toxicology › Product code LGQ · Class 2
Fluorescence Polarization Immunoassay, Phenobarbital
Regulation 862.3660
0510(k)s in 12 months (12 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in LGQ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 1997 | K972331 | INNOFLUOR GENTAMICIN ASSAY SYSTEM Oxis Intl., Inc. | LGQ |
| Jul 14, 1997 | K972330 | INNOFLUOR PHENOBARBITAL ASSAY SYSTEM Oxis Intl., Inc. | LGQ |
| Jun 21, 1994 | K940596 | AXSYM PHENOBARBITAL Abbott Laboratories | LGQ |
| Mar 11, 1994 | K936130 | COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORS Roche Diagnostic Systems, Inc. | LGQ |
| Apr 12, 1990 | K900704 | MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRA Innotron of Oregon, Inc. | LGQ |
| Aug 28, 1989 | K894525 | FPR PHENOBARBITAL KIT Colony Laboratories, Inc. | LGQ |
| Jul 21, 1987 | K872397 | COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI. Roche Diagnostic Systems, Inc. | LGQ |
| Nov 10, 1986 | K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT Windsor Laboratories, Inc. | LGQ |
| Jul 16, 1986 | K862528 | IMMPULSE PHENOBARBITAL ASSAY REAGENTS Sclavo, Inc. | LGQ |
| Oct 28, 1985 | K854044 | TDX BARBITURATES Abbott Laboratories | LGQ |
| Feb 1, 1985 | K843825 | COBAS REAGENTS PHENOBARBITAL & PHENOBAR Roche Diagnostic Systems, Inc. | LGQ |
| May 23, 1984 | K841707 | INNOFLUOR PHENOBARBITAL Innotron Diagnostics | LGQ |
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