Cleared Traditional

MDA D-DIMER

K000492 · Organon Teknika Corp. · Hematology

Jun 2000

Decision

113d

Days

Class 2

Risk

About This 510(k) Submission

K000492 is an FDA 510(k) clearance for the MDA D-DIMER, a Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control (Class II — Special Controls, product code DAP), submitted by Organon Teknika Corp. (Durham, US). The FDA issued a Cleared decision on June 7, 2000, 113 days after receiving the submission on February 15, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7320.

Submission Details

510(k) Number	K000492 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 15, 2000
Decision Date	June 07, 2000
Days to Decision	113 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF

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