Ellagic Acid Aptt Reagent
FDA 510(k) K915418 · Helena Laboratories
510(k) numberK915418
Submission
- Device name
- Ellagic Acid Aptt Reagent
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- December 2, 1991
- Decision date
- February 14, 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 |
|---|---|---|
| K213396 | SPIFE A1AT kitOBZ · Traditional | 10/13/2022SE |
| K192931 | V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional | 04/19/2022SE |
| K131479 | V8 SP Normal Control, Abnormal ControlJJY · Traditional | 10/07/2013SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | 02/23/2007SE |
| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
| K023761 | Plateletworks, Models Pw-A, Pw-CJOZ · Traditional | 02/14/2003SE |
Questions and answers
When was Ellagic Acid Aptt Reagent cleared by the FDA?
Ellagic Acid Aptt Reagent (K915418) received a 510(k) decision of Substantially Equivalent on February 14, 1992, 74 days after the submission was received.
What is the product code of K915418?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.