Cleared Traditional

SYNTHAFAX APTT REAGENT

K955638 · Ortho Diagnostic Systems, Inc. · Hematology
Apr 1996
Decision
134d
Days
Class 2
Risk

About This 510(k) Submission

K955638 is an FDA 510(k) clearance for the SYNTHAFAX APTT REAGENT, a Activated Partial Thromboplastin (Class II — Special Controls, product code GFO), submitted by Ortho Diagnostic Systems, Inc. (Raritan, US). The FDA issued a Cleared decision on April 23, 1996, 134 days after receiving the submission on December 11, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K955638 FDA.gov
FDA Decision Cleared SESE
Date Received December 11, 1995
Decision Date April 23, 1996
Days to Decision 134 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GFO — Activated Partial Thromboplastin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7925

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