Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System
FDA 510(k) K992851 · Roche Diagnostics Corp.
510(k) numberK992851
Submission
- Device name
- Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- August 24, 1999
- Decision date
- January 14, 2000
- 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 |
| 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 |
| K984141 | Gbact + KitJBP · Special | Sienco, Inc. | 05/28/1999SE |
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| K253491 | ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas…CEM · Traditional | 02/12/2026SE |
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Questions and answers
When was Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System cleared by the FDA?
Act Test Catridges for Coaguchek Pro System, Act Controls for Coaguchek Pro System (K992851) received a 510(k) decision of Substantially Equivalent on January 14, 2000, 143 days after the submission was received.
What is the product code of K992851?
The FDA product code is JBP – Activated Whole Blood Clotting Time, a Class II (moderate risk) device regulated under 21 CFR 864.7140.