FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
K Number: K080909
·
Decision Oct 17, 2008
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
4
Review Days
199
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Basic Information
- Device Name
- ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
- K Number
- K080909
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.4700
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ikonisys, Inc.
- Date Received
- April 1, 2008
- Decision Date
- October 17, 2008
- Product Code
- NTH
- Advisory Committee
- Immunology
- 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 |
|---|---|---|---|
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | FDA class 2 | Immunology |
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