Aptt-P Reagent, a Particle Activated Reagent
FDA 510(k) K895255 · Medical Diagnostic Technologies, Inc.
510(k) numberK895255
Submission
- Device name
- Aptt-P Reagent, a Particle Activated Reagent
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- August 21, 1989
- Decision date
- October 6, 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
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| 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.
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|---|---|---|
| K062229 | CTC Workstation, Model 2200LLZ · Traditional | 09/11/2006SE |
| K972209 | Spectrolyse Heparin (Anti-Iia)KFF · Traditional | 08/12/1997SE |
| K963106 | Chromolize PAI-1 KitGGP · Traditional | 11/18/1996SE |
| K960871 | Spectrolyse Antithrombin III (Anti-Xa)JBQ · Traditional | 08/14/1996SE |
| K962489 | Chromolize Tpa Assay KitGGP · Traditional | 07/31/1996SE |
| K960438 | Tintelize PAI-1 KitGGP · Traditional | 06/05/1996SE |
| K961724 | U-Doa ControlsDIF · Traditional | 06/03/1996SE |
| K961370 | La Positive Control PlasmaGGC · Traditional | 05/24/1996SE |
| K955115 | Venom Tiem ReagentJCO · Traditional | 04/03/1996SE |
| K955738 | Bioclot Protein SGGP · Traditional | 02/29/1996SE |
Questions and answers
When was Aptt-P Reagent, a Particle Activated Reagent cleared by the FDA?
Aptt-P Reagent, a Particle Activated Reagent (K895255) received a 510(k) decision of Substantially Equivalent on October 6, 1989, 46 days after the submission was received.
What is the product code of K895255?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.