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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

K222251 is an FDA 510(k) premarket notification submitted by B.R.A.H.M.S GmbH, Part of Thermo Fisher for the device "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". The FDA issued a decision of Substantially Equivalent on September 18, 2023. The device falls under product code QXS (Chromogranin A), a Class II device regulated under 21 CFR 866.6010.

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.

FDA data resources