Cleared Traditional

SYNTHASIL APTT REAGENT

K953981 · Ortho Diagnostic Systems, Inc. · Hematology
Nov 1995
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K953981 is an FDA 510(k) clearance for the SYNTHASIL 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 November 30, 1995, 99 days after receiving the submission on August 23, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7925.

Submission Details

510(k) Number K953981 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 1995
Decision Date November 30, 1995
Days to Decision 99 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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