Aptt Reagent

FDA 510(k) K884856 · Precision Biologicals, Inc.

Substantially Equivalent

510(k) numberK884856

Submission

Device name
Aptt Reagent
Applicant
Precision Biologicals, Inc.
Dartmouth, CA
Received
November 18, 1988
Decision date
January 30, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GFO – Activated Partial Thromboplastin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7925
Specialty
Hematology

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K160445HemosIL Silica Clotting TimeGFO · Special Instrumentation Laboratory CO03/16/2016SE
K053111Sta-Cephascreen KitGFO · Traditional Diagnostica Stago, Inc.05/04/2006SE
K060688Hemosil SynthasilGFO · Special Instrumentation Laboratory CO04/13/2006SE
K050221Hemosil Silica Clotting TimeGFO · Traditional Instrumentation Laboratory CO03/30/2005SE
K022021Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional Vital Scientific N.V.11/01/2002SE
K014028Careside ApttGFO · Traditional Careside Hemotology, Inc.02/08/2002SE
K014008Hemochron Jr. Citrate Aptt CuvetteGFO · Special Itc, Inc.01/24/2002SE
K992712Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional Sigma Diagnostics, Inc.12/06/1999SE

More from Sigma Diagnostics, Inc.

510(k)DeviceDecision
K982062Cryo-Check PNP Platelet Lysate, Model PNP-10GGW · Traditional 01/13/1999SE
K981174Cryo Check Factor Xii Deficient Plasma Model FDP12-10 (1.0ML) and FDP12-15 (1.5ML)GJT · Traditional 01/13/1999SE
K981173Cryo Check Factor Xi Deficient Plasma, Model FDP11-10 (1.OML) and FDP11-15 (1.5ML)GJT · Traditional 01/13/1999SE
K971219Cryo Check Inr Validation SetGGN · Traditional 08/29/1997SE
K971222Cryo Check Apc Resistant PlasmaGGN · Traditional 08/19/1997SE
K971223Cryo Check Factor V Deficient PlasmaGJT · Traditional 07/22/1997SE
K971227Cryo Check Factor X Deficient PlasmaGJT · Traditional 07/18/1997SE
K971226Cryo Check Factor Ix Deficient PlasmaGJT · Traditional 07/18/1997SE
K971225Cryo Check Factor Viii Deficient PlasmaGJT · Traditional 07/17/1997SE
K971224Cryo Check Factor Vii Deficient PlasmaGJT · Traditional 07/17/1997SE

Questions and answers

When was Aptt Reagent cleared by the FDA?

Aptt Reagent (K884856) received a 510(k) decision of Substantially Equivalent on January 30, 1989, 73 days after the submission was received.

What is the product code of K884856?

The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.