Ortho Alt Microwell Test System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K941192 ↗

FDA Product Code

CKD

Device Class

Class I

Regulation

21 CFR Part 862.1030

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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  Class II

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  FDA 510(k) K953981 Active Cleared 30 Nov 1995

• Ortho Result Plus/Pregnancy

  Class II

  FDA 510(k) K894420 Active Cleared 4 Oct 1989

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• Modified Ortho Ebv Vca-Igg Elisa

  Class I

  FDA 510(k) K920412 Active Cleared 22 Jun 1992

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  Class II

  FDA 510(k) K862537 Active Cleared 21 Jul 1986

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