Cleared Traditional

K-ASSAY FIBRINOGEN

K993482 · Kamiya Biomedical Co. · Hematology
Dec 1999
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K993482 is an FDA 510(k) clearance for the K-ASSAY FIBRINOGEN, a Test, Fibrinogen (Class II — Special Controls, product code GIS), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on December 6, 1999, 53 days after receiving the submission on October 14, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7340.

Submission Details

510(k) Number K993482 FDA.gov
FDA Decision Cleared SESE
Date Received October 14, 1999
Decision Date December 06, 1999
Days to Decision 53 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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

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