KJK — Auramine O Class I

FDA Device Classification

Classification Details

Product Code
KJK
Device Class
Class I
Regulation Number
864.1850
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K853081advanced medical technologyAURAMINE O FLUORESCENT MYCOBACTERIAL STAIN SETAugust 13, 1985
K812274carr-scarborough microbiologicalsAURAMINE O MYCROBACTERIAL STAIN SETSeptember 1, 1981