FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
K Number: K013078
·
Decision Jan 10, 2002
Classifications
1
FEI Numbers
13
Registration Numbers
13
Same Product Code
23
Applicant Total
280
Review Days
118
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Basic Information
- Device Name
- ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
- K Number
- K013078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7140
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Helena Laboratories
- Date Received
- September 14, 2001
- Decision Date
- January 10, 2002
- 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 |
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