GHD — Test, Leukocyte Alkaline Phosphatase Class I

FDA Device Classification

Classification Details

Product Code
GHD
Device Class
Class I
Regulation Number
864.7660
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K904022sigma chemicalNITRO BLUE TETRAZOLIUM REDUCTIONDecember 18, 1990
K903995sigma chemicalNAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KITDecember 13, 1990
K896092sigma chemicalALKALINE PHOSPHATASE, LEUKOCYTE, KITNovember 9, 1989
K811189biodynamicsCHEMSTRIP LJuly 27, 1981