Mikrolab Stockholm Ab

FDA Filings

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

FDA Registration(s)

• Registration Number: 3009335508
• FEI Number: 3009335508
• Name: Rob Norris
• Owner & Operator: Mikrolab Stockholm AB
• Contact Address: Kung Hans vag 3 ; SOLLENTUNA SE-AB Stockholms lan [SE-01] 19268 SE
• Official Correspondent:
  • Fredrik B Johansson
  • 046-08-297900-x
• US Agent:
  • Rob Norris
  • Thermo Fisher Scientific
  • 913 8954303
  • rob.norris@thermofisher.com
• Importing Logistics Registration:
  • Importer: Remel Inc
  • Address: 12076 Santa Fe Trail Drive ; Lenexa, KS 66215 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Santa Fe Trail Dr ; Lenexa, KS 66215 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GTZ Rob Norris [Mikrolab Stockholm AB]	Phadebact CSF Pos control	2012-06-19
PMN K854150 | GTZ Rob Norris [Mikrolab Stockholm AB]	Phadebact Strep A Test	2011-12-09
PMN K850351 | LIC Rob Norris [Mikrolab Stockholm AB]	Phadebact Monoclonal GC	2011-12-09
PMN K844999 | GTJ Rob Norris [Mikrolab Stockholm AB]	Phadebact CSF Test	2011-12-09
PMN K840048 | GTY Rob Norris [Mikrolab Stockholm AB]	Phadebact Streptococcus Test	2011-12-09
PMN K832248 | GTY Rob Norris [Mikrolab Stockholm AB]	Phadebact Strep Pos Control	2011-12-09
PMN K830445 | GTZ Rob Norris [Mikrolab Stockholm AB]	Phadebact Strep F	2011-12-09
PMN K800159 | GTZ Rob Norris [Mikrolab Stockholm AB]	Phadebact Strep D Test	2011-12-09
LSC Rob Norris [Mikrolab Stockholm AB]	Phadebact GC Pos Control	2011-12-09
GWC Rob Norris [Mikrolab Stockholm AB]	Phadebact Pneumococcus TEST	2011-12-09
GRP Rob Norris [Mikrolab Stockholm AB]	Phadebact Haemophillus TEST	2011-12-09
GNA Rob Norris [Mikrolab Stockholm AB]	Phadebact Strep B	2011-12-09