510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K761100Substantially Equivalent

Multi-Cell Ultrafiltration System

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

K761100 is the FDA 510(k) clearance record for MULTI-CELL ULTRAFILTRATION SYSTEM, a class I device, cleared for Amicon, Inc. on under FDA product code JQQ (Dialyzer). FDA records list 20 510(k) clearances for Amicon, Inc., from to . As of , FDA records show no recalls naming K761100.

Clearance record

Decision date
Received
(13 days to decision)
Product code
JQQ Dialyzer
Regulation
21 CFR 862.2050
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Amicon, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JQQ

Trailing 12 months

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

FDA records show no clearances under product code JQQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JQQ, 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