Decalcifier I

No FDA recalls on record, checked 11 Oct 2026.

510(k) Number

K841488 ↗

FDA Product Code

KDX

Device Class

Class I

Regulation

21 CFR Part 864.4010

Advisory Committee

Pathology

FDA Decision

SESE Substantially Equivalent

• Schiff Reagent

  Class I

  FDA 510(k) K883217 Active Cleared 5 Aug 1988

• Cervical Scrapers

  Class II

  FDA 510(k) K863145 Active Cleared 19 Aug 1986

• Neutral Buffered Formalin 10%

  Class I

  FDA 510(k) K830583 Active Cleared 17 Mar 1983

• Knife Maker

  Class I

  FDA 510(k) K863616 Active Cleared 25 Sep 1986

• Millonig's Modified Phosphate Buffered

  Class I

  FDA 510(k) K830582 Active Cleared 17 Mar 1983

• C-E Brush

  Class II

  FDA 510(k) K881921 Active Cleared 19 Jul 1988

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