Cleared Traditional

BEHRING COAGULATION SYSTEM

K970431 · Behring Diagnostics, Inc. · Hematology
May 1997
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K970431 is an FDA 510(k) clearance for the BEHRING COAGULATION SYSTEM, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Behring Diagnostics, Inc. (San Jose, US). The FDA issued a Cleared decision on May 5, 1997, 90 days after receiving the submission on February 4, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K970431 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1997
Decision Date May 05, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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