JCG — Fluid, Diluting, Manual Cell Class I

FDA Device Classification

FDA product code JCG covers "Fluid, Diluting, Manual Cell", a Class I medical device regulated under 21 CFR 864.8200. 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
JCG
Device Class
Class I
Regulation Number
864.8200
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K892658scientific distributorsSDI PREPAX COUNTAPETTE KITMay 24, 1989