FDA Device Entity Profile: Bioteque America, Inc.

Known Identifiers & Locations

FEI Numbers 1000121341, 3024860690

Owner Operator Numbers 9053395

Locations Covered Richardson, TX, US

Registered Establishments (1)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3024860690	BIOTEQUE AMERICA, INC.	Richardson, TX, US	Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0027-05	Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch Reason: product is marketed without a 510(k)	2005-02-24	Terminated	View Details

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