510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K855214Substantially Equivalent

Cat-3 Catecholamine Assay Kit

Whale Scientific, Inc., Commerce City CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K855214 is the FDA 510(k) clearance record for CAT-3 CATECHOLAMINE ASSAY KIT, a class I device, cleared for Whale Scientific, Inc. on under FDA product code CHQ (Chromatographic/Fluorometric Method, Catecholamines). FDA records list 3 510(k) clearances for Whale Scientific, Inc., from to . As of , FDA records show no recalls naming K855214.

Clearance record

Decision date
Received
(74 days to decision)
Product code
CHQ Chromatographic/Fluorometric Method, Catecholamines
Regulation
21 CFR 862.1165
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Whale Scientific, Inc. 4945 Monaco St., Commerce City CO
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