GFS — Standards And Controls, Hemoglobin, Normal And Abnormal Class II

FDA Device Classification

Classification Details

Product Code
GFS
Device Class
Class II
Regulation Number
864.8625
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K023032bioresource technologyLIQUITROL, LIQUID HUMAN GLYCOSYLA,TED HEMOGLOBIN (A1C) CONTROL - NORMAL/ABNORMALOctober 8, 2002