Cleared Traditional

OPUS D-DIMER

K972316 · Behring Diagnostics, Inc. · Hematology
Sep 1997
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K972316 is an FDA 510(k) clearance for the OPUS D-DIMER, a Fibrin Split Products (Class II — Special Controls, product code GHH), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on September 9, 1997, 81 days after receiving the submission on June 20, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number K972316 FDA.gov
FDA Decision Cleared SESE
Date Received June 20, 1997
Decision Date September 09, 1997
Days to Decision 81 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GHH — Fibrin Split Products
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7320

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