Ortho(Tm) Recombiplastin W/Ortho Diluent

• • Terminated Z-1247-06 FDA Unclassified (pre-2012) ·initiated 7 Mar 2006

  Firm received 2 complaints concerning incorrect prothrombin time (PT) results while using the reagents on samples of patients taking the antibiotic CUBICIN (Daptomycin for injection).

510(k) Number

K925604 ↗

FDA Product Code

GJS

Device Class

Class II

Regulation

21 CFR Part 864.7750

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  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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