FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
K Number: K080910
·
Decision Feb 4, 2009
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
3
Review Days
309
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Basic Information
- Device Name
- PATHIAM SYSTEM FOR HER2/NEU IMMUNOHISTOCHEMISTRY REAGENTS & KITS
- K Number
- K080910
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bioimagene, Inc.
- Date Received
- April 1, 2008
- Decision Date
- February 4, 2009
- Product Code
- NOT
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| NOT | Microscope, Automated, Image Analysis, Operator Intervention | FDA class 2 | Hematology |
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