Acs Freeze-Dried Aptt Reagent

Q: What is the product code of K921223?

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

FDA 510(k) K921223 · Analytical Control Systems, Inc.

Substantially Equivalent

510(k) numberK921223

Submission

Device name: Acs Freeze-Dried Aptt Reagent
Applicant: Analytical Control Systems, Inc.
Indianapolis, IN, US
Received: March 13, 1992
Decision date: August 18, 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: GFO – Activated Partial Thromboplastin
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.7925
Specialty: Hematology

Other 510(k)s with product code GFO

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K193556	Cryocheck Hex LAGFO · Traditional	Precision Biologic	10/23/2020SE
K160445	HemosIL Silica Clotting TimeGFO · Special	Instrumentation Laboratory CO	03/16/2016SE
K053111	Sta-Cephascreen KitGFO · Traditional	Diagnostica Stago, Inc.	05/04/2006SE
K060688	Hemosil SynthasilGFO · Special	Instrumentation Laboratory CO	04/13/2006SE
K050221	Hemosil Silica Clotting TimeGFO · Traditional	Instrumentation Laboratory CO	03/30/2005SE
K022021	Vital Scientific Aptt, Aptt & Quikcoag ApttGFO · Traditional	Vital Scientific N.V.	11/01/2002SE
K014028	Careside ApttGFO · Traditional	Careside Hemotology, Inc.	02/08/2002SE
K014008	Hemochron Jr. Citrate Aptt CuvetteGFO · Special	Itc, Inc.	01/24/2002SE
K992712	Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional	Sigma Diagnostics, Inc.	12/06/1999SE

More from Sigma Diagnostics, Inc.

510(k)	Device	Decision
K961892	Specktin-La Test SetGFO · Traditional	03/07/1997SE
K941115	Acs Cardio-Trol ControlJJY · Traditional	07/20/1994SE
K940272	Acs Normal Angiotensin Converting Enzyme ControlJJX · Traditional	04/20/1994SE
K940397	Acs O Dilvent Protein Dilution MatrixJJY · Traditional	03/11/1994SE
K930477	Acs Angiotensin Converting Enzyme (Ace) CalibratorJIS · Traditional	06/07/1993SE
K926012	Acs Apct Reagent, ModifiedGFO · Traditional	04/27/1993SE
K925340	Coagulation Control Containing HemoglobinJPA · Traditional	03/23/1993SE
K925906	Normal Angiotensin Converting Enzyme ControlJJX · Traditional	02/18/1993SE
K921118	Acs Apct ReagentGFO · Traditional	07/28/1992SE
K913249	Acs ULTRA-1 ThromboplastinGJS · Traditional	12/04/1991SE

Questions and answers

When was Acs Freeze-Dried Aptt Reagent cleared by the FDA?

Acs Freeze-Dried Aptt Reagent (K921223) received a 510(k) decision of Substantially Equivalent on August 18, 1992, 158 days after the submission was received.

What is the product code of K921223?

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