Karen Gutekunst

FDA Filings

This page includes the latest FDA filings for Karen Gutekunst. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3007102730
• FEI Number: 3007102730
• Name: Karen Gutekunst
• Owner & Operator: Illumina
• Contact Address: 5200 Illumina Way ; San Diego CA 92122 US
• Official Correspondent:
  • Karen Gutekunst
  • x-858-2555541-x
• US Agent:
  • Karen Gutekunst
  • ILLUMINA
  • 858 2555541
  • kgutekunst@illumina.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5200 Illumina Way ; San Diego, CA 92122 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PFF Karen Gutekunst [Illumina]	NextSeq? 550Dx Instrument	2017-12-04
PFT Karen Gutekunst [Illumina]	TruSeq? Custom Amplicon Kit Dx	2017-09-01
PFT Karen Gutekunst [Illumina]	TruSeq? Custom Amplicon Kit Dx- FFPE	2017-09-01
PFT Karen Gutekunst [Illumina]	NextSeq? 550Dx High Output Reagent Kit v2.5 (75 cycles)	2017-09-01
PFT Karen Gutekunst [Illumina]	NextSeq? 550Dx High Output Reagent Kit v2.5 (300 cycles)	2017-09-01
PFT Karen Gutekunst [Illumina]	NextSeq? 550Dx High Output Reagent Kit v2 (300 cycles)	2017-09-01
PFT Karen Gutekunst [Illumina]	MiSeq?Dx Reagent Kit V3	2017-09-01

Similar & Related FDA Registered Companies

• ILLUMINA