# K191030: Applied Biosystems™ 3500 Dx Genetic Analyzer and Applied Biosystems™ 3500xL Dx Genetic Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Life Technologies Corporation
- Decided: Feb 21, 2020 after 309 days
- Product code: PCA (Dna Genetic Analyzer)
- Device class: 2
- Regulation: 21 CFR 862.2570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K761228 (1976). 26 ancestors in all.
No later device cites it as a predicate yet.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110039: Biomet Sports Medicine Sternal Closure System, Biomet Sports Medicine (2011) Summary page 5.

## Indications for use
The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are in vitro diagnostic devices intended for detection of fluorescently-labeled human genomic deoxyribonucleic acid (DNA) nucleotides by capillary electrophoresis. The Applied Biosystems™ 3500 Dx Genetic Analyzer and the Applied Biosystems™ 3500xL Dx Genetic Analyzer are indicated for sequencing and fragment analysis using FDA- cleared or approved assays.

Source page: https://510kreport.com/device/K191030
Methodology: https://510kreport.com/methodology