JBO — Test, Euglobulin Lysis Class II

FDA Device Classification

FDA product code JBO covers "Test, Euglobulin Lysis", a Class II medical device regulated under 21 CFR 864.7275. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
JBO
Device Class
Class II
Regulation Number
864.7275
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K831055olympusHEMOGLOBIN ELECTROPHORESIS METH ON THE-June 8, 1983