FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARIOL HER-2/NEU IHC
K Number: K031715
·
Decision Jan 8, 2004
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
7
Review Days
220
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Basic Information
- Device Name
- ARIOL HER-2/NEU IHC
- K Number
- K031715
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.1860
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Applied Imaging Corp.
- Date Received
- June 2, 2003
- Decision Date
- January 8, 2004
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NOT), ordered by most recent decision date.
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VIRTUOSO SYSTEM FOR IHC KI-67 (30-9)
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VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
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SCANSCOPE XT SYSTEM
FDA 510(k)
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Other Clearances by Applied Imaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K043519 | ARIOL HER-2/NEU FISH | Apr 25, 2005 | Substantially Equivalent |
| K042542 | CYTOVISION FOR CEP XY | Jan 10, 2005 | Substantially Equivalent |
| K033200 | ARIOL | Mar 18, 2004 | Substantially Equivalent |
| K001420 | SLIDESCAN | Aug 30, 2000 | Substantially Equivalent |
| K980375 | WINSCAN AUTOMATED IMAGING SYSTEM | Jun 9, 1998 | Substantially Equivalent |
| K902311 | GENEVISION - COMPUTER ASSISTED CHROMOSOME KARYO. | Aug 20, 1990 | Substantially Equivalent |