FDA Device Entity Profile: RANDOX LABORATORIES, LTD.

Known Identifiers & Locations

FEI Numbers 3003059701, 3004493545, 3009473156, 3014607865

Owner Operator Numbers 8020890

Locations Covered ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB; CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB; Dungloe Donegal, IE; Kearneysville, WV, US

Registered Establishments (4)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
2086993	RANDOX LABORATORIES-US, LTD	Kearneysville, WV, US	Repack or Relabel Medical Device	View Details
3004493545	RANDOX LABORATORIES LIMITED	CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, GB	Manufacture Medical Device	View Details
3009473156	Randox Teoranta	Dungloe Donegal, IE	Foreign Private Label Distributor	View Details
3014607865	RANDOX LABORATORIES LIMITED	ANTRIM, COUNTY ANTRIM Antrim and Newtownabbey, GB	Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device,Repack or Relabel Medical Device	View Details

510(k) Premarket Notifications (1)

Submission #	Device Name	Decision Date	Decision Description	Action
K043267	POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 2	2005-02-10	Substantially Equivalent	View Details

FDA Recall History (0)

No recall records found for this entity.

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