DBY · Class I · 21 CFR 866.5520

FDA Product Code DBY: Fab, Rhodamine, Antigen, Antiserum, Control

Leading manufacturers include Boston Scientific, W.L. Gore & Associates, Inc. and Becton Dickinson Infusion Therapy Systems, Inc..

6
Total
6
Cleared
61d
Avg days
1977
Since

FDA 510(k) Cleared Fab, Rhodamine, Antigen, Antiserum, Control Devices (Product Code DBY)

6 devices
1–6 of 6
Cleared Sep 11, 2002
CONVOY ADVANCED DELIVERY SHEATH
K022067
Boston Scientific
Immunology · 78d
Cleared Jan 02, 2002
BD INTROSYTE PRECISION INTRODUCER, BD INTROSYTE AUTOGAURD SHIELDED INTRODUCER
K013304
Becton Dickinson Infusion Therapy Systems, Inc.
Immunology · 90d
Cleared Dec 14, 2001
GORE INTRODUCER SHEATH
K013282
W.L. Gore & Associates, Inc.
Immunology · 73d
Cleared Dec 14, 2001
CONVOY ADVANCED DELIVERY SHEATH KIT
K013866
Boston Scientific
Immunology · 23d
Cleared Jul 14, 1977
RHODAMINE-CONJUGATED ANTISERUM
K771144
Kent Laboratories, Inc.
Immunology · 17d

About Product Code DBY - Regulatory Context