DEN160047 is an FDA 510(k) submission for the ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M. This device is classified as a Flow Cytometric Test System For Hematopoietic Neoplasms (Class II - Special Controls, product code PWD).
Submitted by Beckman Coulter (Miami, US). The FDA issued a Not Cleared (DENG) decision on June 29, 2017.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.7010. Reagents Intended For In Vitro Diagnostic Use As A Panel For Qualitative Identification Of Cell Populations By Multiparameter Immunophenotyping On A Flow Cytometer. These Reagents Are Used As An Aid In The Differential Diagnosis Of Hematologically Abnormal Patients Having, Or Suspected Of Having The Following Hematopoietic Neoplasms: Chronic Leukemia, Acute Leukemia, Non-hodgkin's Lymphoma, Myeloma, Myelodysplastic Syndrome (mds), And/or Myeloproliferative Neoplasms (mpn).
| 510(k) Number | DEN160047 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 03, 2016 |
| Decision Date | June 29, 2017 |
| Days to Decision | 269 days |
| Submission Type | Direct |
| Review Panel | Immunology (IM) |
| Summary | - |
| Product Code | PWD - Flow Cytometric Test System For Hematopoietic Neoplasms |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7010 |
| Definition | Reagents Intended For In Vitro Diagnostic Use As A Panel For Qualitative Identification Of Cell Populations By Multiparameter Immunophenotyping On A Flow Cytometer. These Reagents Are Used As An Aid In The Differential Diagnosis Of Hematologically Abnormal Patients Having, Or Suspected Of Having The Following Hematopoietic Neoplasms: Chronic Leukemia, Acute Leukemia, Non-hodgkin's Lymphoma, Myeloma, Myelodysplastic Syndrome (mds), And/or Myeloproliferative Neoplasms (mpn) |