K183592 is an FDA 510(k) clearance for the ClearLLab 10C Panels (B, T, M1, M2), Navios Flow Cytometer, Navios EX Flow Cytometer. 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 Cleared decision on March 21, 2019, 90 days after receiving the submission on December 21, 2018.
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 | K183592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 2018 |
| Decision Date | March 21, 2019 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| 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) |