KSP — Apparatus, Cell-Freezing And Reagents Class I

FDA Device Classification

FDA product code KSP covers "Apparatus, Cell-Freezing And Reagents", a Class I medical device regulated under 21 CFR 864.9225. 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
KSP
Device Class
Class I
Regulation Number
864.9225
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K881465cryodyne technologiesCRYOBIOLOGICAL FREEZERApril 21, 1988