510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K924347Substantially Equivalent

Waters(tm) 996 Pda

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

K924347 is the FDA 510(k) clearance record for WATERS(TM) 996 PDA, a class I device, cleared for Millipore Corp. on under FDA product code KIE (Apparatus, High Pressure Liquid Chromatography). FDA records list 94 510(k) clearances for EMD MILLIPORE CORPORATION, from to . As of , FDA records show no recalls naming K924347.

Clearance record

Decision date
Received
(106 days to decision)
Product code
KIE Apparatus, High Pressure Liquid Chromatography
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Millipore Corp. 34 Maple St., Milford MA
510(k) summary
Statement
Third party review
No

Clearances, product code KIE

Trailing 12 months

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

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