FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CD-CHEX PLUS BC
K Number: K051633
·
Decision Aug 16, 2005
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
7
Applicant Total
33
Review Days
57
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Basic Information
- Device Name
- CD-CHEX PLUS BC
- K Number
- K051633
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Streck
- Date Received
- June 20, 2005
- Decision Date
- August 16, 2005
- Product Code
- GGL
- 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 |
|---|---|---|---|
| GGL | Control, White-Cell | FDA class 2 | Hematology |
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