510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931148Substantially Equivalent

Model 5500 Coulochem Electrode Array System

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

K931148 is the FDA 510(k) clearance record for MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM, a class I device, cleared for Esa, Inc. on under FDA product code CHQ (Chromatographic/Fluorometric Method, Catecholamines). FDA records list 4 510(k) clearances for Esa, Inc., from to . As of , FDA records show no recalls naming K931148.

Clearance record

Decision date
Received
(96 days to decision)
Product code
CHQ Chromatographic/Fluorometric Method, Catecholamines
Regulation
21 CFR 862.1165
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Esa, Inc. 45 Wiggins Ave., Bedford MA
510(k) summary
Summary
Third party review
No

Clearances, product code CHQ

Trailing 12 months

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

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