Ortho-Mune Ok-Combo Control IGG2A-Fitc/IGG2A-Pe Monoclonal Antibody (Murine)

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K951632 ↗

FDA Product Code

GKZ

Device Class

Class II

Regulation

21 CFR Part 864.5220

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

See all devices from Ortho Diagnostic Systems, Inc. →