Xylene

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K881282 ↗

FDA Product Code

KEM

Device Class

Class I

Regulation

21 CFR Part 864.4010

Advisory Committee

Pathology

FDA Decision

SESE Substantially Equivalent

• Harris Hematoxylin

  Class I

  FDA 510(k) K872498 Active Cleared 9 Jul 1987

• Zinc Formalin Concentrate

  Class I

  FDA 510(k) K882268 Active Cleared 15 Jun 1988

• Refrax Mounting Medium

  Class I

  FDA 510(k) K842986 Active Cleared 21 Aug 1984

• Pro-Soft Dehydrant

  Class I

  FDA 510(k) K842863 Active Cleared 21 Aug 1984

• Dry-Form

  Class I

  FDA 510(k) K872663 Active Cleared 6 Aug 1987

• Pro-Par Clearant

  Class I

  FDA 510(k) K842861 Active Cleared 21 Aug 1984

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