Product code GLY— Hematology

FDA has cleared 5 devices under product code GLY between 1989 and 2005, filed by 4 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.

• 20051 clearance
• 19991 clearance
• 19962 clearances
• 19891 clearance

• Nova Biomedical Corp.2 clearances
• Radiometer America, Inc.1 clearance
• Nir Diagnostics, Inc.1 clearance
• Avl Scientific Corp.1 clearance

• K050014 — HEMONIR TMNir Diagnostics, Inc.·2005-05-05
• K993104 — STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATORNova Biomedical Corp.·1999-12-02
• K955013 — NOVA CO-OXIMETER ANALYZERNova Biomedical Corp.·1996-04-25
• K952725 — MULTICHECKRadiometer America, Inc.·1996-02-20
• K895466 — AVL MODEL 912 CO-OXYLITEAvl Scientific Corp.·1989-11-06