Cleared Traditional

K-ASSAY AT-III

K000361 · Kamiya Biomedical Co. · Hematology
Apr 2000
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K000361 is an FDA 510(k) clearance for the K-ASSAY AT-III, a Antithrombin Iii Quantitation (Class II — Special Controls, product code JBQ), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on April 26, 2000, 82 days after receiving the submission on February 4, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7060.

Submission Details

510(k) Number K000361 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 2000
Decision Date April 26, 2000
Days to Decision 82 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JBQ — Antithrombin Iii Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7060

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