ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
FDA 510(k) clearance K080909 · decided 2008-10-17
Clearance details
- K-number
- K080909
- Device name
- ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
- Applicant
- Ikonisys, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-04-01
- Decision date
- 2008-10-17
- Days to decision
- 199 days
- Clearance type
- Traditional
- Product code
- NTH
- Device class
- 2
- Regulation number
- 866.4700
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- New Haven, CT, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ikonisys
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DUET SYSTEM (K130775) | Bioview , Ltd. | 2014-05-09 |
| GENASIS SCANVIEW SYSTEM (K122554) | Applied Spectral Imaging , Ltd. | 2013-02-07 |
| SCANVIEW SYSTEM (K110345) | Applied Spectral Imaging | 2011-10-19 |
| SCANVIEW HER2/NEU FISH SYSTEM (K101291) | Applied Spectral Imaging , Ltd. | 2010-11-23 |
| ARIOL HER-2/NEU FISH (K043519) | Applied Imaging Corp. | 2005-04-25 |
| CYTOVISION FOR CEP XY (K042542) | Applied Imaging Corp. | 2005-01-10 |
| VYSIS AUTOVYSION SYSTEM (DEN040010) | Vysis | 2004-12-13 |
Recalls involving this device
No recalls on record reference this clearance.