Automated Hdl Cholesterol Flex Reagent Cartridge, Model DF48A

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K053157 ↗

FDA Product Code

LBS

Device Class

Class I

Regulation

21 CFR Part 862.1475

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K981622 Active Cleared 8 Jun 1998

• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

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  Class I

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