510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160047Unknown

ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M

Siemens Healthcare Diagnostics Inc., Miami FL / Direct, Unknown
FDA source (opens on fda.gov)

DEN160047 is the FDA 510(k) clearance record for ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M, a class II device, cleared for Beckman Coulter on under FDA product code PWD (Flow Cytometric Test System For Hematopoietic Neoplasms). FDA's definition for product code PWD 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...". FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming DEN160047.

Clearance record

Decision date
Received
(269 days to decision)
Product code
PWD Flow Cytometric Test System For Hematopoietic Neoplasms
Regulation
21 CFR 864.7010
Device class
Class II
Review panel
Hematology
Applicant
Beckman Coulter 11800 SW 147th Ave., Miami FL
Third party review
No

Clearances, product code PWD

Trailing 12 months

FDA records hold no clearances under product code PWD in the trailing twelve months.

FDA records show no clearances under product code PWD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PWD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260