Cleared Traditional

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

K143470 · Diazyme Laboratories · Hematology
Jan 2016
Decision
422d
Days
Class 2
Risk

About This 510(k) Submission

K143470 is an FDA 510(k) clearance for the Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Diazyme Laboratories (Poway, US). The FDA issued a Cleared decision on January 31, 2016, 422 days after receiving the submission on December 5, 2014. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K143470 FDA.gov
FDA Decision Cleared SESE
Date Received December 05, 2014
Decision Date January 31, 2016
Days to Decision 422 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GIS — Test, Fibrinogen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7340

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