Hemochron Thrombochronometer
FDA 510(k) K832189 · International Technidyne Corp.
510(k) numberK832189
Submission
- Device name
- Hemochron Thrombochronometer
- Applicant
- International Technidyne Corp.
Walker, MI, US - Received
- July 8, 1983
- Decision date
- October 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBP – Activated Whole Blood Clotting Time
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7140
- Specialty
- Hematology
Other 510(k)s with product code JBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223635 | Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot ViewerJBP · Special | Sienco, Inc. | 01/04/2023SE |
| K062604 | Rapidteg Teg-Act TestJBP · Traditional | Haemoscope Corp. | 01/31/2007SE |
| K032952 | Aiact KitJBP · Traditional | Sienco, Inc. | 12/12/2003SE |
| K023582 | I-Stat Kaolin Act TestJBP · Traditional | I-Stat Corporation | 09/08/2003SE |
| K020914 | Actalyke XL Activated Clotting Time Analyzer, Model 5770JBP · Traditional | Helena Laboratories | 05/23/2002SE |
| K013078 | Actalyke Mini Activated Clotting Time Test System, Model 5750/5752JBP · Traditional | Helena Laboratories | 01/10/2002SE |
| K002528 | Sonoclot Coagulation & Platelet Function Analyzer System with Signature Viewer OptionJBP · Special | Sienco, Inc. | 08/31/2000SE |
| K994194 | (Tas) Low Range Heparin Management Card RapidpointJBP · Traditional | Cardiovascular Diagnostics, Inc. | 03/28/2000SE |
| K992571 | I-Stat SystemJBP · Traditional | I-Stat Corp. | 02/10/2000SE |
| K992851 | Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro SystemJBP · Traditional | Roche Diagnostics Corp. | 01/14/2000SE |
More from Roche Diagnostics Corp.
| 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 Hemochron Thrombochronometer cleared by the FDA?
Hemochron Thrombochronometer (K832189) received a 510(k) decision of Substantially Equivalent on October 14, 1983, 98 days after the submission was received.
What is the product code of K832189?
The FDA product code is JBP – Activated Whole Blood Clotting Time, a Class II (moderate risk) device regulated under 21 CFR 864.7140.