Cleared Traditional

K-ASSAY D-DIMER CONTROLS

K012422 · Kamiya Biomedical Co. · Hematology
Aug 2001
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K012422 is an FDA 510(k) clearance for the K-ASSAY D-DIMER CONTROLS, a Control, Plasma, Abnormal (Class II — Special Controls, product code GGC), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on August 21, 2001, 22 days after receiving the submission on July 30, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K012422 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 2001
Decision Date August 21, 2001
Days to Decision 22 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GGC — Control, Plasma, Abnormal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

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