510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K895105Substantially Equivalent

High Pressure Inert Plastic Columns for Clin. Use

Waters Chemical Products, Milford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K895105 is the FDA 510(k) clearance record for HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE, a class I device, cleared for Waters Chemical Products on under FDA product code DPM (Columns, Liquid Chromatography). FDA records list 2 510(k) clearances for Waters Chemical Products, from to . As of , FDA records show no recalls naming K895105.

Clearance record

Decision date
Received
(52 days to decision)
Product code
DPM Columns, Liquid Chromatography
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Waters Chemical Products 34 Maple St., Milford MA
Third party review
No

Clearances, product code DPM

Trailing 12 months

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

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