FDA product code DBY: Fab, Rhodamine, Antigen, Antiserum, Control
DBY is the FDA product code for fab, rhodamine, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel. FDA has cleared 6 510(k) submissions under DBY, from 5 different applicants. The average 510(k) review took 61 days (median 76).
Classification
| Field | Value |
|---|---|
| Device name | Fab, Rhodamine, Antigen, Antiserum, Control |
| Device class | Class I |
| Regulation | 21 CFR 866.5520 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every DBY clearance
Top DBY applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific | 2 | 2002-09-11 |
| Baylis Medical Co., Inc. | 1 | 2002-02-22 |
| Becton Dickinson Infusion Therapy Systems, Inc. | 1 | 2002-01-02 |
| W. L. Gore & Associates, Inc. | 1 | 2001-12-14 |
| Kent Laboratories, Inc. | 1 | 1977-07-14 |
Most recent DBY clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022067 | Boston Scientific | CONVOY ADVANCED DELIVERY SHEATH | 2002-09-11 | 78 |
| K013919 | Baylis Medical Co., Inc. | TORFLEX TRANSSEPTAL GUIDING SHEATH | 2002-02-22 | 87 |
| K013304 | Becton Dickinson Infusion Therapy Systems, Inc. | BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER | 2002-01-02 | 90 |
| K013866 | Boston Scientific | CONVOY ADVANCED DELIVERY SHEATH KIT | 2001-12-14 | 23 |
| K013282 | W. L. Gore & Associates, Inc. | GORE INTRODUCER SHEATH | 2001-12-14 | 73 |
Recalls for DBY devices
openFDA lists no recalls for product code DBY.
Frequently asked questions
What is FDA product code DBY?
DBY is the FDA product code for fab, rhodamine, antigen, antiserum, control. It is a Class I device, regulated under 21 CFR 866.5520 and reviewed by the Immunology panel.
What device class is DBY?
Class I, regulation 21 CFR 866.5520. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code DBY?
Across 6 cleared submissions the average was 61 days from receipt to decision (median 76).
Which companies have the most DBY clearances?
Boston Scientific (2); Baylis Medical Co., Inc. (1); Becton Dickinson Infusion Therapy Systems, Inc. (1); W. L. Gore & Associates, Inc. (1); Kent Laboratories, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code DBY
- Run a recall and safety report across every DBY manufacturer
- Watch product code DBY for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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