Hemochron Onestep Aptt Test
FDA 510(k) K915344 · International Technidyne Corp.
510(k) numberK915344
Submission
- Device name
- Hemochron Onestep Aptt Test
- Applicant
- International Technidyne Corp.
Edison, NJ, US - Received
- November 26, 1991
- Decision date
- February 11, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253957 | HemosIL Silica Clotting TimeGFO · Special | Instrumentation Laboratory (IL) Co. | 01/09/2026SE |
| 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 |
|---|---|---|
| K120977 | Directcheck Control for Hemochron Jr. Microcoagulation Systems Act-Lr Cuvette…GGN · Traditional | 07/03/2013SE |
| K050983 | Irma Trupoint Creatinine Control KitJJX · Traditional | 05/16/2005SE |
| K050016 | Hemochron Signature EliteJPA · Traditional | 02/10/2005SE |
| K030818 | Hemochron Response/SystemJPA · Special | 04/02/2003SE |
| K023561 | Itc HGB Pro Professional Hemoglobin Testing SystemGKR · Traditional | 01/31/2003SE |
| K020798 | Hemochron Jr. Signature +JPA · Special | 03/28/2002SE |
| K010599 | Protime Microcoagulation System / Protime 3 CuvetteGJS · Special | 07/02/2001SE |
| K010193 | Hemochron Kaolin-Activated Heparin and Protamine Dosing AssaysKFF · Traditional | 06/06/2001SE |
| K983475 | Hemochron ResponseKQG · Traditional | 05/03/1999SE |
| K990449 | Hemochron Electronic System Verification TubeJPA · Traditional | 04/13/1999SE |
Questions and answers
When was Hemochron Onestep Aptt Test cleared by the FDA?
Hemochron Onestep Aptt Test (K915344) received a 510(k) decision of Substantially Equivalent on February 11, 1992, 77 days after the submission was received.
What is the product code of K915344?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.