Product code LGQ— Clinical Toxicology

FDA has cleared 12 devices under product code LGQ between 1984 and 1997, filed by 8 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.

• 19972 clearances
• 19942 clearances
• 19901 clearance
• 19891 clearance
• 19871 clearance
• 19862 clearances
• 19852 clearances
• 19841 clearance

• Roche Diagnostic Systems, Inc.3 clearances
• Oxis Intl., Inc.2 clearances
• Abbott Laboratories2 clearances
• Windsor Laboratories, Inc.1 clearance
• Sclavo, Inc.1 clearance
• Innotron of Oregon, Inc.1 clearance
• Innotron Diagnostics1 clearance
• Colony Laboratories, Inc.1 clearance

• K972331 — INNOFLUOR GENTAMICIN ASSAY SYSTEMOxis Intl., Inc.·1997-08-01
• K972330 — INNOFLUOR PHENOBARBITAL ASSAY SYSTEMOxis Intl., Inc.·1997-07-14
• K940596 — AXSYM PHENOBARBITALAbbott Laboratories·1994-06-21
• K936130 — COBAS-FP REAGENT FOR PHENOBARBITAL AND COBAS-FP PHENOBARBITAL CALIBRATORSRoche Diagnostic Systems, Inc.·1994-03-11
• K900704 — MODIFIED ACCUFLUOR PHENOBARBITAL REAGENT & CALIBRAInnotron of Oregon, Inc.·1990-04-12
• K894525 — FPR PHENOBARBITAL KITColony Laboratories, Inc.·1989-08-28
• K872397 — COBAS FP REAGENTS FOR PHENO & COBAS FP PHENO CALI.Roche Diagnostic Systems, Inc.·1987-07-21
• K863625 — PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KITWindsor Laboratories, Inc.·1986-11-10
• K862528 — IMMPULSE PHENOBARBITAL ASSAY REAGENTSSclavo, Inc.·1986-07-16
• K854044 — TDX BARBITURATESAbbott Laboratories·1985-10-28
• K843825 — COBAS REAGENTS PHENOBARBITAL & PHENOBARRoche Diagnostic Systems, Inc.·1985-02-01
• K841707 — INNOFLUOR PHENOBARBITALInnotron Diagnostics·1984-05-23