Stratus Folate Fluorometric Enzyme-Linked Assay

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K923286 ↗

FDA Product Code

CGN

Device Class

Class II

Regulation

21 CFR Part 862.1295

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class I

  FDA 510(k) K914202 Active Cleared 11 Oct 1991

• Bartels Herpes Simplex Virus 2 Igg Eia

  Class II

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• Dried Gram-Negative Mic/Combo Panels

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  Class II

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• Dried Gram Negative/Cefmetazole

  Class II

  FDA 510(k) K941317 Active Cleared 31 Jan 1995

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