510(k) K080909
- Device
- ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
- Applicant
- Ikonisys, Inc.
- 510(k) number
- K080909
- Product code
- NTH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-10-17
- Date received
- 2008-04-01
- Regulation
- 866.4700
- Classification name
- System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- SYED ATAULLAH
- Address
- 5 Science Park Suite 1000 New Haven CT US 06511 06511
FDA Registration Numbers#
- 9615060
- 3005248192
- 3003909093
Source Documents#
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|---|---|---|---|
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| K110345 | SCANVIEW SYSTEM | Applied Spectral Imaging | 2011-10-19 |
| K101291 | SCANVIEW HER2/NEU FISH SYSTEM | Applied Spectral Imaging , Ltd. | 2010-11-23 |
| K043519 | ARIOL HER-2/NEU FISH | Applied Imaging Corp. | 2005-04-25 |
| K042542 | CYTOVISION FOR CEP XY | Applied Imaging Corp. | 2005-01-10 |
| DEN040010 | VYSIS AUTOVYSION SYSTEM | Vysis | 2004-12-13 |