FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONTROL PLASMA P
K Number: K023312
·
Decision Nov 1, 2002
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
343
Review Days
29
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Basic Information
- Device Name
- CONTROL PLASMA P
- K Number
- K023312
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dade Behring, Inc.
- Date Received
- October 3, 2002
- Decision Date
- November 1, 2002
- Product Code
- GGC
- 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 |
|---|---|---|---|
| GGC | Control, Plasma, Abnormal | FDA class 2 | Hematology |
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