COAG-1 Aptt Test Card
FDA 510(k) K891015 · Cardiovascular Diagnostic Services
510(k) numberK891015
Submission
- Device name
- COAG-1 Aptt Test Card
- Applicant
- Cardiovascular Diagnostic Services
Research Triangle Park, NC, US - Received
- February 28, 1989
- Decision date
- May 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K955843 | Tas PtoneGJS · Traditional | 03/18/1996SE |
| K933092 | Tas AnalyzerGKP · Traditional | 11/15/1993SE |
| K904325 | COAG-1 Pt-Nc Test CardGJS · Traditional | 01/25/1991SE |
| K903019 | Modified COAG-1 PT Test CardGJS · Traditional | 08/01/1990SE |
| K882456 | Coag-I PT Test CardGJS · Traditional | 08/25/1988SE |
| K882444 | Coag-I Analyzer, Alpha ModelJPA · Traditional | 08/25/1988SE |
| K812304 | Dorros-Spring PressurizerMAV · Traditional | 10/13/1981SE |
Questions and answers
When was COAG-1 Aptt Test Card cleared by the FDA?
COAG-1 Aptt Test Card (K891015) received a 510(k) decision of Substantially Equivalent on May 22, 1989, 83 days after the submission was received.
What is the product code of K891015?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.