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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device panels, test, susceptibility, antimicrobial
Regulation Description Antimicrobial susceptibility test powder.
Product CodeLTT
Regulation Number 866.1640
Device Class 2


Premarket Reviews
ManufacturerDecision
BECKMAN COULTER, INC.
  SUBSTANTIALLY EQUIVALENT 3

Recalls
Manufacturer Recall Class Date Posted
1 Beckman Coulter, Inc. II Apr-08-2026
2 Beckman Coulter, Inc. II Apr-03-2026
3 Beckman Coulter, Inc. II Mar-20-2026
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