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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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New Search show TPLC since Back to Search Results
Device system, test, immunological, antigen, tumor
Product CodeMOI
Regulation Number 866.6010
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIREBIO DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ROCHE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS HEALTHCARE DIAGNOSTICS
  SUBSTANTIALLY EQUIVALENT 1
  1.  K100344  DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDG ...
SIEMENS HEALTHCARE DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter Inc. II May-12-2017
2 Siemens Healthcare Diagnostics, Inc II Sep-03-2021
3 Siemens Healthcare Diagnostics, Inc II Apr-06-2017
4 Siemens Healthcare Diagnostics, Inc II Dec-11-2012
5 Siemens Healthcare Diagnostics, Inc II Oct-28-2012
6 Siemens Healthcare Diagnostics, Inc. II Aug-29-2022
7 Siemens Healthcare Diagnostics, Inc. II May-04-2018
8 Tosoh Bioscience Inc II Jun-05-2018
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