Product code LGR— Clinical Toxicology

FDA has cleared 15 devices under product code LGR between 1984 and 1996, filed by 11 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19962 clearances
• 19952 clearances
• 19943 clearances
• 19901 clearance
• 19891 clearance
• 19871 clearance
• 19861 clearance
• 19851 clearance
• 19843 clearances

• Abbott Laboratories3 clearances
• Roche Diagnostic Systems, Inc.2 clearances
• Innotron of Oregon, Inc.2 clearances
• Windsor Laboratories, Inc.1 clearance
• Sigma Diagnostics, Inc.1 clearance
• Sclavo, Inc.1 clearance
• Pb Diagnostic Systems, Inc.1 clearance
• Oxis Intl., Inc.1 clearance
• Innotron Diagnostics1 clearance
• Ciba Corning Diagnostics Corp.1 clearance

• K955873 — ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.·1996-03-11
• K955562 — INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.·1996-01-24
• K953840 — AXSYM PHENYTOIN IIAbbott Laboratories·1995-09-25
• K946328 — TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott Laboratories·1995-03-28
• K943313 — PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.·1994-10-27
• K935375 — AXSYM PHENYTOIN ASSAYAbbott Laboratories·1994-06-21
• K936131 — COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORSRoche Diagnostic Systems, Inc.·1994-03-11
• K896868 — OPUS PHENYTOIN TEST SYSTEMPb Diagnostic Systems, Inc.·1990-01-02
• K895827 — INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SETInnotron of Oregon, Inc.·1989-10-31
• K872563 — INNOTRON INNOFLUOR PHEYTOIN REAGENT SETInnotron of Oregon, Inc.·1987-08-21
• K862554 — IMMPULSE PHENYTOIN ASSAY REAGENTSclavo, Inc.·1986-07-16
• K843824 — COBAS FP REAGENTS FOR PHENYTOIN & CALIBRRoche Diagnostic Systems, Inc.·1985-02-01
• K844171 — PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTEBd Becton Dickinson Vacutainer Systems Preanalytic·1984-12-10
• K842586 — PHENYTOIN KIT FLUORESCENCE POLARIZATIONWindsor Laboratories, Inc.·1984-09-26
• K841706 — INNOFLUOR PHENYTOINInnotron Diagnostics·1984-05-22