Actalyke XL Activated Clotting Time Analyzer, Model 5770
FDA 510(k) K020914 · Helena Laboratories
510(k) numberK020914
Submission
- Device name
- Actalyke XL Activated Clotting Time Analyzer, Model 5770
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- March 21, 2002
- Decision date
- May 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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|---|---|---|---|
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| K023582 | I-Stat Kaolin Act TestJBP · Traditional | I-Stat Corporation | 09/08/2003SE |
| 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 |
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Questions and answers
When was Actalyke XL Activated Clotting Time Analyzer, Model 5770 cleared by the FDA?
Actalyke XL Activated Clotting Time Analyzer, Model 5770 (K020914) received a 510(k) decision of Substantially Equivalent on May 23, 2002, 63 days after the submission was received.
What is the product code of K020914?
The FDA product code is JBP – Activated Whole Blood Clotting Time, a Class II (moderate risk) device regulated under 21 CFR 864.7140.