FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PLASMACON N, PLASMACON L-1, PLASMACON L-2
K Number: K062306
·
Decision Mar 16, 2007
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
39
Applicant Total
10
Review Days
220
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Basic Information
- Device Name
- PLASMACON N, PLASMACON L-1, PLASMACON L-2
- K Number
- K062306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- R2 Diagnostics, Inc.
- Date Received
- August 8, 2006
- Decision Date
- March 16, 2007
- 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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