K222251 is an FDA 510(k) clearance for the 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. This device is classified as a Chromogranin A (Class II - Special Controls, product code QXS).
Submitted by B.R.A.H.M.S GmbH, Part of Thermo Fisher (Hennigsdorf, DE). The FDA issued a Cleared decision on September 18, 2023, 418 days after receiving the submission on July 27, 2022.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.6010. 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..
| 510(k) Number | K222251 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 27, 2022 |
| Decision Date | September 18, 2023 |
| Days to Decision | 418 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | QXS - Chromogranin A |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.6010 |
| 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. |