510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PWDClass II

Flow Cytometric Test System For Hematopoietic Neoplasms

21 CFR 864.7010 / Hematology
FDA source (opens on fda.gov)

PWD is the FDA product code for Flow Cytometric Test System For Hematopoietic Neoplasms, a class II device type, regulated under 21 CFR 864.7010. FDA's definition for this code reads: "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...". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PWD
Device name
Flow Cytometric Test System For Hematopoietic Neoplasms
FDA 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)
Regulation
21 CFR 864.7010
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code PWD

By decision year
2 clearances under product code PWD with a decision year between 2017 and 2019, 2017 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code PWD by decision year
YearClearances
20171
20191

Applicants with the most clearances

Product code PWD
Applicants holding the most 510(k) clearances under product code PWD
ApplicantClearances
Siemens Healthcare Diagnostics Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code