510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K905538Substantially Equivalent

Columns Liquid Chromatography Dpm

Millpore Corp., Milford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K905538 is the FDA 510(k) clearance record for COLUMNS LIQUID CHROMATOGRAPHY DPM, a class I device, cleared for Millpore Corp. on under FDA product code KZR (Chromatography (Liquid, Gel), Clinical Use). FDA records list one 510(k) clearance for Millpore Corp. As of , FDA records show no recalls naming K905538.

Clearance record

Decision date
Received
(45 days to decision)
Product code
KZR Chromatography (Liquid, Gel), Clinical Use
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Millpore Corp. Waters Chromatography Division, Milford MA
Third party review
No

Clearances, product code KZR

Trailing 12 months

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

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