FDP Plasma Test Kit

Q: What is the product code of K920943?

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.

FDA 510(k) K920943 · American Bioproducts Co.

Substantially Equivalent

510(k) numberK920943

Submission

Device name: FDP Plasma Test Kit
Applicant: American Bioproducts Co.
Parsippany, NJ, US
Received: February 27, 1992
Decision date: July 13, 1992
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

Other 510(k)s with product code DAP

510(k)	Device	Applicant	Decision
K253985	INNOVANCE® D-Dimer 2.0 (SMN 10873803)DAP · Traditional	Siemens Healthcare Diagnostic Products GmbH	08/11/2026SE
K172903	HemosIL D-Dimer HS 500DAP · Special	Instrumentation Laboratory CO	11/22/2017SE
K162227	STA® - Liatest® D-DiDAP · Traditional	Diagnostica Stago	12/10/2016SE
K160885	HemosIL D-Dimer HSDAP · Special	Instrumentation Laboratory CO	10/27/2016SE
K151534	HemosIL D-Dimer HSDAP · Special	Instrumentation Laboratory CO	07/06/2015SE
K141144	Sta Liatest D-DiDAP · Traditional	Diagnostica Stago	09/03/2014SE
K112818	Vidas D-Dimer Exclusion II (DEX2)DAP · Traditional	bioMerieux, Inc.	07/31/2012SE
K110303	Stratus CS Acute Care D-DimerDAP · Traditional	Siemens Healthcare Diagnostics	05/16/2011SE
K093626	Innovance D-Dimer, Model OPBP09DAP · Traditional	Siemens Healthcare Diagnostics	11/29/2010SE
K090264	Hemosil D-Dimer HS 500, ControlsDAP · Traditional	Instrumentation Laboratory CO	02/05/2010SE

More from Instrumentation Laboratory CO

510(k)	Device	Decision
K983460	Star Automated Multi-Parametric AnalyzerJPA · Traditional	11/12/1998SE
K971519	Asserachrom Tpa Test KitGGP · Traditional	08/19/1997SE
K964728	Sta-Liatest D-Di Test KitDAP · Traditional	06/26/1997SE
K964716	Sta Liatest Control [N]+[P] KitGGN · Traditional	06/26/1997SE
K964718	Sta D-Di Calibrator KitDAP · Traditional	05/23/1997SE
K962675	Sta - Liatest VWF Test KitGJT · Traditional	10/25/1996SE
K962671	Sta-Vwf Calibrator KitGJT · Traditional	09/13/1996SE
K962674	Sta - VWF Control [N]+[P] KitGGN · Traditional	07/23/1996SE
K961579	Sta Compact Automated Multi-Parametric AnalyzerGKP · Traditional	07/10/1996SE
K955040	At-Iii Control Plasma KitGGC · Traditional	01/31/1996SE

Questions and answers

When was FDP Plasma Test Kit cleared by the FDA?

FDP Plasma Test Kit (K920943) received a 510(k) decision of Substantially Equivalent on July 13, 1992, 137 days after the submission was received.

What is the product code of K920943?

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.