Product code LGI— Clinical Toxicology

FDA has cleared 3 devices under product code LGI between 1990 and 1994, filed by 3 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.

• 19942 clearances
• 19901 clearance

• Sigma Diagnostics, Inc.1 clearance
• Innotron of Oregon, Inc.1 clearance
• Abbott Laboratories1 clearance

• K944063 — FLUORESCENCE POLARIZATION IMMUNOASSAY CARBAMAZEPINESigma Diagnostics, Inc.·1994-11-10
• K940682 — AXSYM(TM) QUINIDINEAbbott Laboratories·1994-06-21
• K900702 — MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRAInnotron of Oregon, Inc.·1990-04-12