Product code LCO— Hematology

FDA has cleared 13 devices under product code LCO between 1986 and 2025, filed by 9 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.

• 20251 clearance
• 20202 clearances
• 20171 clearance
• 20161 clearance
• 20072 clearances
• 20061 clearance
• 20041 clearance
• 20011 clearance
• 19991 clearance
• 19891 clearance
• 19861 clearance

• Genetic Testing Institute3 clearances
• Instrumentation Laboratory CO2 clearances
• Immucor Gti Diagnostics, Inc.2 clearances
• Instrumentation Laboratory (IL) Co.1 clearance
• Hyphen Biomed1 clearance
• Diagnostica Stago, Inc.1 clearance
• Behring Diagnostics, Inc.1 clearance
• American Bioproducts Co.1 clearance
• Akers Laboratories, Inc.1 clearance

• K243374 — HemosIL CL HIT-IgG(PF4-H)Instrumentation Laboratory (IL) Co.·2025-01-28
• K201570 — PF4 Enhanced assayImmucor Gti Diagnostics, Inc.·2020-09-11
• K201311 — PF4 IgG assayImmucor Gti Diagnostics, Inc.·2020-06-18
• K170854 — HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT ControlsInstrumentation Laboratory CO·2017-09-08
• K153137 — HemosIL HIT-Ab(PF4-H), HemosIL HIT-Ab(PF4-H) ControlsInstrumentation Laboratory CO·2016-07-08
• K071781 — PF4 IGGGenetic Testing Institute·2007-12-19
• K071255 — ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040AHyphen Biomed·2007-09-07
• K053559 — PF4 ENHANCED SOLID PHASE ELISAGenetic Testing Institute·2006-01-20
• K040293 — HEALTHTEST HEPARIN/PLATELET FACTOR 4 ANTIBODY ASSAYAkers Laboratories, Inc.·2004-05-28
• K003767 — ASSERACHROM HPIA TEST KITDiagnostica Stago, Inc.·2001-02-12
• K983379 — GTI-PF4 ELISAGenetic Testing Institute·1999-03-09
• K890633 — ENZYGNOST PLATELET FACTOR 4 (PF4) KITBehring Diagnostics, Inc.·1989-04-21
• K862774 — ASSERACHROM PF4 KITAmerican Bioproducts Co.·1986-09-04