The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteque 3 In 1 Hemodialysis Blood Tubing Pack.
| Device ID | K013634 |
| 510k Number | K013634 |
| Device Name: | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK |
| Classification | Set, Tubing, Blood, With And Without Anti-regurgitation Valve |
| Applicant | BIOTEQUE CORP. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich BIOTEQUE CORP. 3892 SOUTH AMERICA WEST TRAIL Flaggstaff, AZ 86001 |
| Product Code | FJK |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2002-07-09 |
| Summary: | summary |