GIG — Hemoglobinometer Class II

FDA Device Classification

Classification Details

Product Code
GIG
Device Class
Class II
Regulation Number
864.7500
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K973995randox laboratoriesRANDOX BILIRUBINDecember 8, 1997
K933836artelHBM HEMOGLOBINOMETERMarch 31, 1994
K771101dow chemicalHEMOGLOBIN ANALYZER & PERFORM. CHECK SETJuly 21, 1977