MGA — Alpha-1 Microglobulin, Antigen, Antiserum, Control Class I

FDA Device Classification

FDA product code MGA covers "Alpha-1 Microglobulin, Antigen, Antiserum, Control", a Class I medical device regulated under 21 CFR 866.5400. Submissions are reviewed by the Immunology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
MGA
Device Class
Class I
Regulation Number
866.5400
Submission Type
Review Panel
IM
Medical Specialty
Immunology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K965033beckman instrumentsIMMAGE IMMUNOCHEMISTRY SYSTEM ALPHA-1-MICROGLOBULIN (AI) REAGENTApril 21, 1997
K933078beckman instrumentsBECKMAN ALPHA-1-MICROGLOBULIN (A1M) REAGENTJanuary 11, 1994