510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K943978Substantially Equivalent

Waters Pico Tag Chem Pack/free Amino Acid Analysis

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

K943978 is the FDA 510(k) clearance record for WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS, a class I device, cleared for Waters Chromatography Division on under FDA product code JJF (Analyzer, Chemistry, Micro, For Clinical Use). FDA records list one 510(k) clearance for Waters Chromatography Division. As of , FDA records show no recalls naming K943978.

Clearance record

Decision date
Received
(259 days to decision)
Product code
JJF Analyzer, Chemistry, Micro, For Clinical Use
Regulation
21 CFR 862.2170
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Waters Chromatography Division 34 Maple St., Milford MA
510(k) summary
Statement
Third party review
No

Clearances, product code JJF

Trailing 12 months

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

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