FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APPLIED BIOSYSTEMS 7500 FAST DX
K Number: K082562
·
Decision Sep 30, 2008
Classifications
1
FEI Numbers
63
Registration Numbers
63
Same Product Code
12
Applicant Total
1
Review Days
26
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
- APPLIED BIOSYSTEMS 7500 FAST DX
- K Number
- K082562
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Biosystems, Inc.
- Date Received
- September 4, 2008
- Decision Date
- September 30, 2008
- Product Code
- NSU
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- 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