510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K903231Substantially Equivalent

Coulochem II

Esa, Inc., Bedford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903231 is the FDA 510(k) clearance record for COULOCHEM II, a class I device, cleared for Esa, Inc. on under FDA product code LEQ (Detectors, Electrochemical, Liquid Chromatography). FDA records list 4 510(k) clearances for Esa, Inc., from to . As of , FDA records show no recalls naming K903231.

Clearance record

Decision date
Received
(66 days to decision)
Product code
LEQ Detectors, Electrochemical, Liquid Chromatography
Regulation
21 CFR 862.2260
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Esa, Inc. 45 Wiggins Ave., Bedford MA
Third party review
No

Clearances, product code LEQ

Trailing 12 months

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

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