GJH — Stain, Reticulocyte Class I

FDA Device Classification

FDA product code GJH covers "Stain, Reticulocyte", a Class I medical device regulated under 21 CFR 864.1850. 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
GJH
Device Class
Class I
Regulation Number
864.1850
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K790042geometric data, div. smithklineSTAIN, HEMASTAIN RETICFebruary 15, 1979