FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARIOL
K Number: K033200
·
Decision Mar 18, 2004
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
14
Applicant Total
7
Review Days
168
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Basic Information
- Device Name
- ARIOL
- K Number
- K033200
- 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
- October 2, 2003
- Decision Date
- March 18, 2004
- Product Code
- NQN
- 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 |
|---|---|---|---|
| NQN | Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity | FDA class 2 | Hematology |
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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 |
| K031715 | ARIOL HER-2/NEU IHC | Jan 8, 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 |