FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer
K Number: K191030
·
Decision Feb 21, 2020
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
0
Applicant Total
3
Review Days
309
Basic Information
- Device Name
- Applied Biosystems 3500 Dx Genetic Analyzer and Applied Biosystems 3500xL Dx Genetic Analyzer
- K Number
- K191030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Life Technologies Corporation
- Date Received
- April 18, 2019
- Decision Date
- February 21, 2020
- Product Code
- PCA
- 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 |
|---|---|---|---|
| PCA | Dna Genetic Analyzer | FDA class 2 | Clinical Chemistry |