FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FIBROSYSTEM
K Number: K823520
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
0
Applicant Total
632
Review Days
29
Basic Information
- Device Name
- FIBROSYSTEM
- K Number
- K823520
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.7900
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
- Date Received
- November 29, 1982
- Decision Date
- December 28, 1982
- Product Code
- GKQ
- 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 |
|---|---|---|---|
| GKQ | Test, Thromboplastin Generation | FDA class 1 | Hematology |
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