KTO — Reagent, Immunoassay, Igg Class I

FDA Device Classification

Classification Details

Product Code
KTO
Device Class
Class I
Regulation Number
866.5530
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K894416reagents applicationsRAICHEM(TM) SPIA(TM) IGG REAGENTSAugust 1, 1989
K854483kallestad laboratoriesKALLESTAD QUANTIMETRIC PLUS IGG REAGENT KITDecember 11, 1985