Device classification

Records

• Automated Urinalysis System

  Clinical Chemistry · 21 CFR 862.2900

  Class IProduct code KQOExempt
  FDA page
• Apparatus, Electrosurgical

  General, Plastic Surgery · 21 CFR 878.4400

  Class IIProduct code HAM
  FDA page
• Monitor, Heart Sound, Fetal, Ultrasonic

  Obstetrics/Gynecology · 21 CFR 884.2660

  Class IIProduct code HEK
  FDA page
• Heparin, Vascular Access Flush

  General Hospital · 21 CFR 880.5200

  Class IIProduct code NZW
  FDA page
• Monitor, U.V., Glc

  Clinical Chemistry · 21 CFR 862.2250

  Class IProduct code JXQExempt
  FDA page
• Kit, Identification, Dermatophyte

  Microbiology · 21 CFR 866.2660

  Class IProduct code JSRExempt
  FDA page
• Neurosurgical Laser With Mr Thermography

  General, Plastic Surgery · 21 CFR 878.4810

  Class IIProduct code ONO
  FDA page
• Electrophoretic Separation, Lipoproteins

  Clinical Chemistry · 21 CFR 862.1475

  Class IProduct code JHOExempt
  FDA page
• Coating, Filling Material, Resin

  Dental · 21 CFR 872.3310

  Class IIProduct code EBD
  FDA page
• Apparatus, Hemoperfusion, Sorbent

  Gastroenterology, Urology · 21 CFR 876.5870

  Class IIProduct code FLD
  FDA page
• Interventional Fluoroscopic X-Ray System

  Radiology · 21 CFR 892.1650

  Class IIProduct code OWB
  FDA page
• Bone Marrow Biopsy Tray

  General, Plastic Surgery · 21 CFR 878.4800

  Class IProduct code PXO
  FDA page
• Plate, Cranioplasty, Preformed, Non-Alterable

  Neurology · 21 CFR 882.5330

  Class IIProduct code GXN
  FDA page
• Antisera, Cf, Coxsackievirus A 1-24, B 1-6

  Microbiology · 21 CFR 866.3145

  Class IProduct code GNOExempt
  FDA page
• Hearing Aid, Air-Conduction, Prescription

  Ear, Nose, Throat · 21 CFR 874.3300

  Class IProduct code ESDExempt
  FDA page
• Ventricular Bypass (Assist) Device

  Cardiovascular · 21 CFR 870.3545

  Class IIIProduct code OKR
  FDA page
• Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite

  Orthopedic · 21 CFR 888.3030

  Class IIProduct code LXT
  FDA page
• Supplement, Culture Media

  Microbiology · 21 CFR 866.2450

  Class IProduct code JSKExempt
  FDA page
• Duodenoscope And Accessories, Flexible/Rigid

  Gastroenterology, Urology · 21 CFR 876.1500

  Class IIProduct code FDT
  FDA page
• Candida Species, Antibody Detection

  Microbiology · 21 CFR 866.3165

  Class IIProduct code LSGExempt
  FDA page