FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BANDVIEW SYSTEM
K Number: K012103
·
Decision Sep 14, 2001
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
7
Review Days
71
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Basic Information
- Device Name
- BANDVIEW SYSTEM
- K Number
- K012103
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5260
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Spectral Imaging , Ltd.
- Date Received
- July 5, 2001
- Decision Date
- September 14, 2001
- Product Code
- LNJ
- 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 |
|---|---|---|---|
| LNJ | Analyzer, Chromosome, Automated | FDA class 2 | Hematology |
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|---|---|---|---|
| K140957 | GENASIS HIPATH IHC FAMILY | Jan 15, 2015 | Substantially Equivalent |
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| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Nov 23, 2010 | Substantially Equivalent |
| K071398 | SCANVIEW, MODEL SC-300 | Oct 4, 2007 | Substantially Equivalent |
| K050236 | FISHVIEW | Jun 27, 2005 | Substantially Equivalent |
| K973950 | RETINAL CUBE | Dec 12, 1997 | Substantially Equivalent |