Aptt by Hemochron(R)
FDA 510(k) K892209 · Intensive Technology, Inc.
510(k) numberK892209
Submission
- Device name
- Aptt by Hemochron(R)
- Applicant
- Intensive Technology, Inc.
Edison, NJ, US - Received
- April 3, 1989
- Decision date
- June 22, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K922970 | Intra-Operative Tec Atherectomy SystemMCW · Traditional | 01/13/1993SE |
| K912664 | Tec Rotating Dual HemovalveDYB · Traditional | 08/24/1992SE |
| K911869 | Ivt Guiding CatheterDQY · Traditional | 10/16/1991SE |
| K903463 | Ivt Introducer SheathDYB · Traditional | 01/03/1991SE |
| K904003 | Hemochron(R) Heparin Response TestKFF · Traditional | 11/29/1990SE |
| K901767 | Modified Ivt Peripheral AtherectomyLIT · Traditional | 06/28/1990SE |
| K896403 | Modified Ivt Peripheral Atherectomy SystemLIT · Traditional | 03/06/1990SE |
| K895903 | Ivt 0.014 Guide WireDQX · Traditional | 01/04/1990SE |
| K890515 | Peripheral Atherectomy SystemDWX · Traditional | 05/23/1989SE |
| K882804 | 0.014 Peripheral Guide WireDQX · Traditional | 10/28/1988SE |
Questions and answers
When was Aptt by Hemochron(R) cleared by the FDA?
Aptt by Hemochron(R) (K892209) received a 510(k) decision of Substantially Equivalent on June 22, 1989, 80 days after the submission was received.
What is the product code of K892209?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.