FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MICROSPIN 24
K Number: K953519
·
Decision Nov 3, 1995
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
14
Applicant Total
1
Review Days
99
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Basic Information
- Device Name
- MICROSPIN 24
- K Number
- K953519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5600
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vulcon Technologies
- Date Received
- July 27, 1995
- Decision Date
- November 3, 1995
- Product Code
- GKF
- 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 |
|---|---|---|---|
| GKF | Instrument, Hematocrit, Automated | FDA class 2 | Hematology |
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