FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
K Number: K964609
·
Decision Mar 6, 1997
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
23
Applicant Total
3
Review Days
108
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
- K Number
- K964609
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7140
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Array Medical, Inc.
- Date Received
- November 18, 1996
- Decision Date
- March 6, 1997
- Product Code
- JBP
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JBP | Activated Whole Blood Clotting Time | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JBP), ordered by most recent decision date.
Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer
FDA 510(k)
FDA Class 2
·Hematology
RAPIDTEG TEG-ACT TEST
FDA 510(k)
FDA Class 2
·Hematology
AIACT KIT
FDA 510(k)
FDA Class 2
·Hematology
I-STAT KAOLIN ACT TEST
FDA 510(k)
FDA Class 2
·Hematology
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
FDA 510(k)
FDA Class 2
·Hematology
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
FDA 510(k)
FDA Class 2
·Hematology