Product code CGL— Clinical Chemistry

FDA has cleared 8 devices under product code CGL between 1991 and 2026, 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.

• 20261 clearance
• 20171 clearance
• 20121 clearance
• 20071 clearance
• 20061 clearance
• 19991 clearance
• 19971 clearance
• 19911 clearance

• Nova Biomedical Corp.2 clearances
• Swedish Trade Council USA1 clearance
• Radiometer Medical Aps1 clearance
• Nova Biomedical Corporation1 clearance
• I-Stat Corp.1 clearance
• Epocal, Inc.1 clearance
• Abbott Point of Care, Inc.1 clearance

• K261039 — i-STAT Crea cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.·2026-06-26
• K171059 — Nova StatSensor Creatinine Hospital Meter SystemNova Biomedical Corporation·2017-05-26
• K113726 — EPOC CHLORIDE TEST AND EPOC CREATININE TESTEpocal, Inc.·2012-10-05
• K070068 — NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPSNova Biomedical Corp.·2007-05-07
• K051968 — ABL8X7 FLEXRadiometer Medical Aps·2006-10-16
• K991727 — STAT PROFILE M7 ANALYZERNova Biomedical Corp.·1999-07-16
• K973292 — I-STAT SYSTEMI-Stat Corp.·1997-10-20
• K903034 — RENALYZER PRX 90Swedish Trade Council USA·1991-03-13