Cleared Traditional

DESTINY MAX COAGULATION ANALYZER

K083896 · Trinity Biotech · Hematology
Jul 2009
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K083896 is an FDA 510(k) clearance for the DESTINY MAX COAGULATION ANALYZER, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Trinity Biotech (Jamestown, US). The FDA issued a Cleared decision on July 2, 2009, 185 days after receiving the submission on December 29, 2008. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K083896 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2008
Decision Date July 02, 2009
Days to Decision 185 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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