Product code LQN— Microbiology

FDA has cleared 13 devices under product code LQN between 1985 and 2003, filed by 7 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.

• 20031 clearance
• 19971 clearance
• 19963 clearances
• 19921 clearance
• 19901 clearance
• 19892 clearances
• 19862 clearances
• 19852 clearances

• Orion Corp.4 clearances
• Sienna Biotech, Inc.2 clearances
• Biokit USA, Inc.2 clearances
• Armkel, LLC2 clearances
• Seradyn, Inc.1 clearance
• Murex Diagnostics, Inc.1 clearance
• Immunostics Inc.,1 clearance

• K031490 — RUBELLACOLImmunostics Inc.,·2003-07-16
• K970931 — COPALIS TORC TOTAL ANTIBODY ASSAYSienna Biotech, Inc.·1997-04-24
• K961784 — COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYSSienna Biotech, Inc.·1996-10-31
• K954920 — MUREX RUB-EXMurex Diagnostics, Inc.·1996-08-21
• K952544 — COLORSLIDER RUBELLASeradyn, Inc.·1996-01-17
• K912391 — RUBALEX, MODIFICATIONOrion Corp.·1992-05-04
• K901637 — RESUBMITTED MODIFIED RUBALEXOrion Corp.·1990-04-26
• K896433 — MODIFIED RUBAGENBiokit USA, Inc.·1989-11-29
• K893755 — RUBAGENBiokit USA, Inc.·1989-08-21
• K861881 — RUBALEX (REVISED VERSION)Orion Corp.·1986-06-04
• K852788 — RUBALEXOrion Corp.·1986-03-12
• K844436 — VIROGEN RUBELLA MICROTITER TESTArmkel, LLC·1985-05-21
• K844435 — VIROGEN RUBELLA SLIDE TESTArmkel, LLC·1985-05-20