FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
K Number: K081822
·
Decision Jan 21, 2009
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
270
Review Days
208
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Basic Information
- Device Name
- COULTER 6C CELL CONTROL, MODELS 628027 & A59925
- K Number
- K081822
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Beckman Coulter, Inc.
- Date Received
- June 27, 2008
- Decision Date
- January 21, 2009
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
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