FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CYTOVISION FOR CEP XY
K Number: K042542
·
Decision Jan 10, 2005
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
7
Review Days
112
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- CYTOVISION FOR CEP XY
- K Number
- K042542
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.4700
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Applied Imaging Corp.
- Date Received
- September 20, 2004
- Decision Date
- January 10, 2005
- Product Code
- NTH
- Advisory Committee
- Immunology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| NTH | System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (Fish) Assays | FDA class 2 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NTH), ordered by most recent decision date.
DUET SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
GENASIS SCANVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SCANVIEW SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
SCANVIEW HER2/NEU FISH SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000
FDA 510(k)
FDA Class 2
·Immunology
ARIOL HER-2/NEU FISH
FDA 510(k)
FDA Class 2
·Immunology
Other Clearances by Applied Imaging Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K043519 | ARIOL HER-2/NEU FISH | Apr 25, 2005 | Substantially Equivalent |
| K033200 | ARIOL | Mar 18, 2004 | 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 |