PDA699/PDA700 Protamine Dose Assay for Hep. Neutra
FDA 510(k) K870831 · International Technidyne Corp.
510(k) numberK870831
Submission
- Device name
- PDA699/PDA700 Protamine Dose Assay for Hep. Neutra
- Applicant
- International Technidyne Corp.
Edison, NJ, US - Received
- March 3, 1987
- Decision date
- June 1, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPA – System, Multipurpose For In Vitro Coagulation Studies
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K232018 | Citrated: K, KH, RTH, FFHJPA · Traditional | Haemonetics Corporation | 03/29/2024SE |
| K233790 | Acl Top 970 CLJPA · Special | Instrumentation Laboratory | 12/29/2023SE |
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| K201440 | ROTEM sigma Thromboelastometry SystemJPA · Traditional | Tem Innovations GmbH | 07/08/2022SE |
| K202101 | GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional | Accriva Diagnostics, Inc. | 12/29/2021SE |
More from Accriva 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 PDA699/PDA700 Protamine Dose Assay for Hep. Neutra cleared by the FDA?
PDA699/PDA700 Protamine Dose Assay for Hep. Neutra (K870831) received a 510(k) decision of Substantially Equivalent on June 1, 1987, 90 days after the submission was received.
What is the product code of K870831?
The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.