KJF — System, Suspension, Cell Culture Class I

FDA Device Classification

FDA product code KJF covers "System, Suspension, Cell Culture", a Class I medical device regulated under 21 CFR 864.2240. Submissions are reviewed by the Hematology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
KJF
Device Class
Class I
Regulation Number
864.2240
Submission Type
Review Panel
PA
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K893787baxter healthcareLIFECELL RECOVERY CONTAINERJune 23, 1989
K892645amiconAMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SYJune 13, 1989
K875221biological rescue productsTOOTH PRESERVING SYSTEMApril 14, 1988
K780305dynatech laboratoriesCELLMarch 27, 1978