DBY
6 FDA 510(k) clearances · Product code
78 daysmedian time to decision
90 days90th percentile
6clearances measured
FDA profile
- Official device name
- Fab, Rhodamine, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5520
- Medical specialty
- Immunology
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CONVOY ADVANCED DELIVERY SHEATH (K022067) | Boston Scientific | 2002-09-11 |
| TORFLEX TRANSSEPTAL GUIDING SHEATH (K013919) | Baylis Medical Co., Inc. | 2002-02-22 |
| BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER (K013304) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-01-02 |
| GORE INTRODUCER SHEATH (K013282) | W. L. Gore & Associates, Inc. | 2001-12-14 |
| CONVOY ADVANCED DELIVERY SHEATH KIT (K013866) | Boston Scientific | 2001-12-14 |
| RHODAMINE-CONJUGATED ANTISERUM (K771144) | Kent Laboratories, Inc. | 1977-07-14 |
Track DBY automatically
Every clearance here is in the API, with alerts when new ones post.