Protamine Response Test Catalogue Number PRT 200
FDA 510(k) K910105 · International Technidyne Corp.
510(k) numberK910105
Submission
- Device name
- Protamine Response Test Catalogue Number PRT 200
- Applicant
- International Technidyne Corp.
Edison, NJ, US - Received
- January 3, 1991
- Decision date
- February 26, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFT – Protamine Sulphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7525
- Specialty
- Hematology
Other 510(k)s with product code GFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944115 | Heparin Assay Cartridges and ControlsGFT · Traditional | Medtronic Hemotec, Inc. | 03/24/1995SE |
More from Medtronic Hemotec, 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 Protamine Response Test Catalogue Number PRT 200 cleared by the FDA?
Protamine Response Test Catalogue Number PRT 200 (K910105) received a 510(k) decision of Substantially Equivalent on February 26, 1991, 54 days after the submission was received.
What is the product code of K910105?
The FDA product code is GFT – Protamine Sulphate, a Class II (moderate risk) device regulated under 21 CFR 864.7525.