Cleared Traditional

ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT

K935748 · Ortho Diagnostic Systems, Inc. · Hematology
Apr 1995
Decision
511d
Days
Class 2
Risk

About This 510(k) Submission

K935748 is an FDA 510(k) clearance for the ORTHO RECOMBIPLASTIN II W/ORTHO RECOMBIPLASTIN II DILUENT, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on April 26, 1995, 511 days after receiving the submission on December 1, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K935748 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1993
Decision Date April 26, 1995
Days to Decision 511 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750

More from Ortho Diagnostic Systems, Inc.

View all
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
K951459 · GKZ · Jul 1997
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
K951632 · GKZ · Mar 1997
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
K964754 · GKZ · Jan 1997
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · GIS · Nov 1996
ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
K950568 · GKZ · May 1996