The following data is part of a premarket notification filed by Bioteque Corp. with the FDA for Bioteq I.v. (intravenous) Set.
| Device ID | K002449 |
| 510k Number | K002449 |
| Device Name: | BIOTEQ I.V. (INTRAVENOUS) SET |
| Classification | Set, Administration, Intravascular |
| Applicant | BIOTEQUE CORP. 900 N. SWITZER CANYON DR. #142 Flagstaff, AZ 86001 |
| Contact | Jennifer Chen |
| Correspondent | Jennifer Chen BIOTEQUE CORP. 900 N. SWITZER CANYON DR. #142 Flagstaff, AZ 86001 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-09 |
| Decision Date | 2000-12-22 |