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510(k) K191030

Device
Applied Biosystems™ 3500 Dx Genetic Analyzer And Applied Biosystems™ 3500xL Dx Genetic Analyzer
Applicant
Life Technologies Corporation
510(k) number
K191030
Product code
PCA  
Decision
Substantially Equivalent (SESE)
Decision date
2020-02-21
Date received
2019-04-18
Regulation
862.2570
Classification name
Dna Genetic Analyzer
Medical specialty
Clinical Chemistry
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Darcie Baynes
Address
5781 Van Allen Way Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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