510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222251Substantially Equivalent

B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC

B.R.A.H.M.S GmbH, Part of Thermo Fisher, Hennigsdorf, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222251 is the FDA 510(k) clearance record for B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPTOR CAL, B·R·A·H·M·S CgA II KRYPTOR QC, a class II device, cleared for B.R.A.H.M.S GmbH, Part of Thermo Fisher on under FDA product code QXS (Chromogranin A). FDA's definition for product code QXS reads: "In vitro test to measure Chromogranin A (CgA) as an aid in monitoring during the course of disease and treatment in patients with gastroentero-pancreatic neuroendocrine tumors". FDA records list one 510(k) clearance for B.R.A.H.M.S GmbH, Part of Thermo Fisher. As of , FDA records show no recalls naming K222251.

Clearance record

Decision date
Received
(418 days to decision)
Product code
QXS Chromogranin A
Regulation
21 CFR 866.6010
Device class
Class II
Review panel
Immunology
Applicant
B.R.A.H.M.S GmbH, Part of Thermo Fisher Neuendorfstrasse 25, Hennigsdorf, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QXS

Trailing 12 months

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

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