JZH — Factor B, Antigen, Antiserum, Control Class II

FDA Device Classification

Classification Details

Product Code
JZH
Device Class
Class II
Regulation Number
866.5320
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K964843beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENTMarch 6, 1997
K882623technicon instrumentsPROPERDIN FACTOR B FOR TECHNICON DPA-1(TM) SYSTEMJuly 8, 1988
K831959kent laboratoriesRADIAL IMMUNO-TEST FOR HUMAN FACTOR BJuly 19, 1983
K811740kallestad laboratoriesKALLESTAD'S ENDOPLATE FACTOR B TESTJuly 16, 1981
K781016icl scientificC3PA (GBG) PROPERDIN FACTOR BAugust 14, 1978
K772084hyland therapeutic div., travenol laboratoriesLAS-R HUMAN C3 PROACTIVATOR TESTJanuary 24, 1978