Cleared Traditional

K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT

K002948 · Kamiya Biomedical Co. · Hematology

May 2001

Decision

239d

Days

Class 2

Risk

About This 510(k) Submission

K002948 is an FDA 510(k) clearance for the K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on May 18, 2001, 239 days after receiving the submission on September 21, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K002948 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 21, 2000
Decision Date	May 18, 2001
Days to Decision	239 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Statement

Device Classification

Product Code	DAP — Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.7320