GHY — Hematocrit, Tube, Rack, Sealer, Holder Class II

FDA Device Classification

FDA product code GHY covers "Hematocrit, Tube, Rack, Sealer, Holder", a Class II medical device regulated under 21 CFR 864.6400. Submissions are reviewed by the Hematology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
GHY
Device Class
Class II
Regulation Number
864.6400
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K883185norfolk scientificSAFECRIT PLASTIC MICROHEMATOCRIT TUBESAugust 18, 1988
K881186helps productsMICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PLMay 13, 1988