FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
K Number: DEN040012
·
Decision Dec 23, 2004
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
4
Review Days
50
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
- AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM
- K Number
- DEN040012
- Device Class
- FDA class 2
- Clearance Type
- Post-NSE
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Unknown
- Applicant
- Affymetrix, Inc.
- Date Received
- November 3, 2004
- Decision Date
- December 23, 2004
- Product Code
- NSU
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| NSU | Instrumentation For Clinical Multiplex Test Systems | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (NSU), ordered by most recent decision date.
ePlex Instrument
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FilmArray 2.0 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
VANTERA CLINICAL ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
APPLIED BIOSYSTEMS 7500 FAST DX REAL-TIME PCR INSTRUMENT WITH SDS SOFTWARE
FDA 510(k)
FDA Class 2
·Clinical Chemistry
FLEXMAP 3D
FDA 510(k)
FDA Class 2
·Clinical Chemistry
LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P
FDA 510(k)
FDA Class 2
·Clinical Chemistry