510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K032199Substantially Equivalent

Esa Plasma Free Metanephrine Analysis Kit

Esa, Inc., Chelmsford MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032199 is the FDA 510(k) clearance record for ESA PLASMA FREE METANEPHRINE ANALYSIS KIT, a class I device, cleared for Esa, Inc. on under FDA product code CHQ (Chromatographic/Fluorometric Method, Catecholamines). FDA records list 3 510(k) clearances for Esa, Inc., from to . As of , FDA records show no recalls naming K032199.

Clearance record

Decision date
Received
(196 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. 22 Alpha Rd., Chelmsford MA
510(k) summary
Summary PDF
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