Product code LIG— Clinical Chemistry

FDA has cleared 8 devices under product code LIG between 1982 and 2024, filed by 6 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.

• 20241 clearance
• 20071 clearance
• 20061 clearance
• 20031 clearance
• 19992 clearances
• 19901 clearance
• 19821 clearance

• Beckman Coulter, Inc.2 clearances
• Abbott Laboratories2 clearances
• Inova Diagnostics, Inc.1 clearance
• Immco Diagnostics, Inc.1 clearance
• Diagnostic Products Corp.1 clearance
• Corning Medical & Scientific1 clearance

• K240800 — Access Intrinsic Factor AbBeckman Coulter, Inc.·2024-05-03
• K071346 — IMMULISA INTRINSIC FACTOR ANTIBODY ELISAImmco Diagnostics, Inc.·2007-09-24
• K061841 — QUANTA LITE INTRINSIC FACTOR ELISAInova Diagnostics, Inc.·2006-12-22
• K033603 — INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999Beckman Coulter, Inc.·2003-12-19
• K993251 — IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6Diagnostic Products Corp.·1999-11-17
• K984108 — ABBOTT ARCHITECT B12Abbott Laboratories·1999-02-03
• K903218 — IMX B12Abbott Laboratories·1990-08-23
• K811927 — 1F BLOCKING ANTIBODY(57 CO) RADIOASSAYCorning Medical & Scientific·1982-04-01