QXS

Chromogranin A

Product code
QXS
Device name
Chromogranin A
Device class
Class 2
21 CFR
21 CFR 866.6010
Medical specialty
Immunology
Marketing pathway
510(K)
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
1 (all years; only the last 3 years are listed here)

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2023-09-18.

NumberDecision dateApplicantDevice nameSummary
K2222512023-09-18B.R.A.H.M.S GmbH, Part of Thermo Fishe…B·R·A·H·M·S CgA II KRYPTOR, B·R·A·H·M·S CgA II KRYPT…PDF

1 summaries are archived here for direct download.

Official FDA classification page: QXS
Classification and pathway per current FDA publications. Data from openFDA (CC0).