Cleared Traditional

ORTHO(TM) RECOMBIPLASTIN W/ORTHO DILUENT

K925604 · Ortho Diagnostic Systems, Inc. · Hematology
Mar 1993
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K925604 is an FDA 510(k) clearance for the ORTHO(TM) RECOMBIPLASTIN W/ORTHO 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 March 12, 1993, 127 days after receiving the submission on November 5, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K925604 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 1992
Decision Date March 12, 1993
Days to Decision 127 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

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