Tpsa Flex Reagent Cartridge

No FDA recalls on record, checked 10 Oct 2026.

510(k) Number

K031343 ↗

FDA Product Code

LTJ

Device Class

Class II

Regulation

21 CFR Part 866.6010

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

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• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

  FDA 510(k) K033487 Active Cleared 24 Dec 2003

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  Class II

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• Tgl Flex Reagent Cartridge

  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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