Panels › Clinical Toxicology › Product code LGR · Class 2
Fluorescence Polarization Immunoassay, Diphenylhydantoin (Total)
Regulation 862.3350
0510(k)s in 12 months (15 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LGR
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 11, 1996 | K955873 | ACS PHENYTOIN ASSAY Ciba Corning Diagnostics Corp. | LGR |
| Jan 24, 1996 | K955562 | INNOFLUOR PHENYTOIN ASSAY SYSTEM Oxis Intl., Inc. | LGR |
| Sep 25, 1995 | K953840 | AXSYM PHENYTOIN II Abbott Laboratories | LGR |
| Mar 28, 1995 | K946328 | TDX(R)/TDXFLX(R) PHENYTOIN II Abbott Laboratories | LGR |
| Oct 27, 1994 | K943313 | PHENYTOIN FPIA REAGENT SET AND CALIBRATORS Sigma Diagnostics, Inc. | LGR |
| Jun 21, 1994 | K935375 | AXSYM PHENYTOIN ASSAY Abbott Laboratories | LGR |
| Mar 11, 1994 | K936131 | COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS Roche Diagnostic Systems, Inc. | LGR |
| Jan 2, 1990 | K896868 | OPUS PHENYTOIN TEST SYSTEM Pb Diagnostic Systems, Inc. | LGR |
| Oct 31, 1989 | K895827 | INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET Innotron of Oregon, Inc. | LGR |
| Aug 21, 1987 | K872563 | INNOTRON INNOFLUOR PHEYTOIN REAGENT SET Innotron of Oregon, Inc. | LGR |
| Jul 16, 1986 | K862554 | IMMPULSE PHENYTOIN ASSAY REAGENT Sclavo, Inc. | LGR |
| Feb 1, 1985 | K843824 | COBAS FP REAGENTS FOR PHENYTOIN & CALIBR Roche Diagnostic Systems, Inc. | LGR |
| Dec 10, 1984 | K844171 | PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE Bd Becton Dickinson Vacutainer Systems Preanalytic | LGR |
| Sep 26, 1984 | K842586 | PHENYTOIN KIT FLUORESCENCE POLARIZATION Windsor Laboratories, Inc. | LGR |
| May 22, 1984 | K841706 | INNOFLUOR PHENYTOIN Innotron Diagnostics | LGR |
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