510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K941326Substantially Equivalent

Ultrafree-Cl

EMD Millipore Corporation, Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K941326 is the FDA 510(k) clearance record for ULTRAFREE-CL, a class I device, cleared for Millipore Corp. on under FDA product code JJH (Clinical Sample Concentrator). FDA records list 94 510(k) clearances for EMD MILLIPORE CORPORATION, from to . As of , FDA records show no recalls naming K941326.

Clearance record

Decision date
Received
(70 days to decision)
Product code
JJH Clinical Sample Concentrator
Regulation
21 CFR 862.2310
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Millipore Corp. 80 Ashby Rd., Bedford MA
510(k) summary
Statement
Third party review
No

Clearances, product code JJH

Trailing 12 months

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

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