510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892645Substantially Equivalent

Amicon Vitafiber Flo-Path Biorect/vls Cell Cult Sy

Amicon, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K892645 is the FDA 510(k) clearance record for AMICON VITAFIBER FLO-PATH BIORECT/VLS CELL CULT SY, a class I device, cleared for Amicon, Inc. on under FDA product code KJF (System, Suspension, Cell Culture). FDA records list 20 510(k) clearances for Amicon, Inc., from to . As of , FDA records show no recalls naming K892645.

Clearance record

Decision date
Received
(62 days to decision)
Product code
KJF System, Suspension, Cell Culture
Regulation
21 CFR 864.2240
Device class
Class I
Review panel
Hematology
Applicant
Amicon, Inc. 17 Cherry Hill Dr., Danvers MA
Third party review
No

Clearances, product code KJF

Trailing 12 months

FDA records hold no clearances under product code KJF in the trailing twelve months.

FDA records show no clearances under product code KJF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KJF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260