Bioteque America Inc
Richardson, TX, US
BIOTEQUE AMERICA, INC. appears in FDA device records in Richardson, TX. FDA records list 10 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for Bioteque America Inc between 1992 and 2004. The busiest year on record is 1994, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 2 |
| 1994 | 3 |
| 1995 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K041094 | HSG CATHETER SET | LKF | Substantially Equivalent | |
| K020628 | CURELLE, PREFERRED CURELLE, CUTEQ 2.5 | HHK | Substantially Equivalent | |
| K013289 | BIOTEQUE VAGINAL PESSARIES | HHW | Substantially Equivalent | |
| K003380 | BIOTEQUE VAGINAL DILATOR | HDX | Substantially Equivalent | |
| K920633 | PESSARY FLEXIBLE SILICONE NICHOLS | KXP | Substantially Equivalent | |
| K920747 | PESSARY FLEXIBLE SILICONE DONUT RING | HHW | Substantially Equivalent | |
| K933628 | CYTOLOGY BRUSH | HHT | Substantially Equivalent | |
| K933521 | SPECULUM | HIB | Substantially Equivalent | |
| K920187 | FLEXIBLE SILICONE GELIHORN | HHW | Substantially Equivalent | |
| K920177 | VERSA-VIAL | DQF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3024860690 | 3024860690 | BIOTEQUE AMERICA, INC. | 1302 Exchange Drive, Suite # 150, Richardson, TX 75081 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0027-05 | Uterine Introducing Catheter 5F, 300 mm in length. The product is shipped in a sterile tyvek pouch | product is marketed without a 510(k) | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain