FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPUNCRIT
K Number: K925863
·
Decision Feb 5, 1993
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
10
Applicant Total
251
Review Days
78
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Basic Information
- Device Name
- SPUNCRIT
- K Number
- K925863
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- bioMerieux, Inc.
- Date Received
- November 19, 1992
- Decision Date
- February 5, 1993
- Product Code
- GKG
- 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 |
|---|---|---|---|
| GKG | Centrifuge, Hematocrit | FDA class 2 | Hematology |
Similar 510(k) Clearances
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