I-Stat Kaolin Act Test
FDA 510(k) K023582 · I-Stat Corporation
510(k) numberK023582
Submission
- Device name
- I-Stat Kaolin Act Test
- Applicant
- I-Stat Corporation
East Windsor, NJ, US - Received
- October 24, 2002
- Decision date
- September 8, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K984141 | Gbact + KitJBP · Special | Sienco, Inc. | 05/28/1999SE |
More from Sienco, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K053597 | I-Stat B-Type Natriuretic Peptide (BNP)NBC · Traditional | 07/21/2006SE |
| K053110 | Abbott i-STAT Crea Cartridge, Abbott i-STAT G Cartridge, Abbott i-STAT 6+ Cartridge…JGS · Special | 01/13/2006SE |
| K051433 | I-Stat Creatine Kinase MB (Ck-Mb)MYT · Traditional | 12/15/2005SE |
| K031873 | I-Stat Cardiac Markers Control Level 1, 2, and 3; Cardiac Markers Calibration…JJX · Traditional | 10/07/2003SE |
| K031739 | I-Stat Cardiac Troponin (Ctni) TestMMI · Traditional | 09/02/2003SE |
| K020355 | I-Stat Prothrombin Time TestGJS · Traditional | 05/14/2002SE |
| K012478 | Modification to: I-Stat Portable Clinical AnalyzerCHL · Special | 08/20/2001SE |
| K011478 | I-Stat SystemKHP · Traditional | 07/02/2001SE |
| K001387 | I-Stat Portable Clinical Analyzer, Model 300CGA · Traditional | 10/05/2000SE |
| K001154 | I-Stat Model 200 Portable Clinical AnalyzerJGS · Special | 04/18/2000SE |
Questions and answers
When was I-Stat Kaolin Act Test cleared by the FDA?
I-Stat Kaolin Act Test (K023582) received a 510(k) decision of Substantially Equivalent on September 8, 2003, 319 days after the submission was received.
What is the product code of K023582?
The FDA product code is JBP – Activated Whole Blood Clotting Time, a Class II (moderate risk) device regulated under 21 CFR 864.7140.