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510(k) K222251

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 by B.R.A.H.M.S GmbH, Part of Thermo Fisher — Product Code QXS

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: September 18, 2023
Date Received: July 27, 2022
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Chromogranin A
Device Class: Class II
Regulation Number: 866.6010
Review Panel: IM
Submission Type

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.