Microscan Synergies Plus Gram Negative Mic/Combo Panels with Nitrofurantoin (1-256 Ug/Ml)

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K031602 ↗

FDA Product Code

LON

Device Class

Class II

Regulation

21 CFR Part 866.1645

Advisory Committee

Microbiology

FDA Decision

SESE Substantially Equivalent

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  Class I

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• Stratus Cs Acute Care Troponin I Testpak, Model Cctni

  Class II

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• Behring Coagulation System, Model BCS

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  Class II

  FDA 510(k) K012470 Active Cleared 28 Sep 2001

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  Class I

  FDA 510(k) K010871 Active Cleared 9 Jul 2001

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