Ortho* Bi-Level Assayed Glycoh. Contr. S

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K811567 ↗

FDA Product Code

LCP

Device Class

Class II

Regulation

21 CFR Part 864.7470

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

• Ortho*pap-Ia Endogenous Enzyme Immuno

  Class II

  FDA 510(k) K831670 Active Cleared 24 Aug 1983

• Synthasil APTT Reagent

  Class II

  FDA 510(k) K953981 Active Cleared 30 Nov 1995

• Ortho Result Plus/Pregnancy

  Class II

  FDA 510(k) K894420 Active Cleared 4 Oct 1989

• Orthokrome* Plasminogen

  Class II

  FDA 510(k) K900399 Active Cleared 15 Mar 1990

• Modified Ortho Ebv Vca-Igg Elisa

  Class I

  FDA 510(k) K920412 Active Cleared 22 Jun 1992

• Koagulab* M Coagulation System

  Class II

  FDA 510(k) K862537 Active Cleared 21 Jul 1986

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