Miniquant D-Dimer, Model 1447

FDA 510(k) K002642 · Biopool Intl., Inc.

Substantially Equivalent

510(k) numberK002642

Submission

Device name
Miniquant D-Dimer, Model 1447
Applicant
Biopool Intl., Inc.
Ventura, CA, US
Received
August 24, 2000
Decision date
February 5, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7320
Specialty
Hematology

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K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)DAP · Traditional Siemens Healthcare Diagnostic Products GmbH08/11/2026SE
K172903HemosIL D-Dimer HS 500DAP · Special Instrumentation Laboratory CO11/22/2017SE
K162227STA® - Liatest® D-DiDAP · Traditional Diagnostica Stago12/10/2016SE
K160885HemosIL D-Dimer HSDAP · Special Instrumentation Laboratory CO10/27/2016SE
K151534HemosIL D-Dimer HSDAP · Special Instrumentation Laboratory CO07/06/2015SE
K141144Sta Liatest D-DiDAP · Traditional Diagnostica Stago09/03/2014SE
K112818Vidas D-Dimer Exclusion II (DEX2)DAP · Traditional bioMerieux, Inc.07/31/2012SE
K110303Stratus CS Acute Care D-DimerDAP · Traditional Siemens Healthcare Diagnostics05/16/2011SE
K093626Innovance D-Dimer, Model OPBP09DAP · Traditional Siemens Healthcare Diagnostics11/29/2010SE
K090264Hemosil D-Dimer HS 500, ControlsDAP · Traditional Instrumentation Laboratory CO02/05/2010SE

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Questions and answers

When was Miniquant D-Dimer, Model 1447 cleared by the FDA?

Miniquant D-Dimer, Model 1447 (K002642) received a 510(k) decision of Substantially Equivalent on February 5, 2001, 165 days after the submission was received.

What is the product code of K002642?

The FDA product code is DAP – Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 864.7320.