DBA · Class II · 21 CFR 866.5250

FDA Product Code DBA: Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control

Leading manufacturers include The Binding Site Group , Ltd., Hyland Therapeutic Div., Travenol Laboratories and Icl Scientific.

13
Total
13
Cleared
90d
Avg days
1978
Since

FDA 510(k) Cleared Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control Devices (Product Code DBA)

13 devices
1–13 of 13
Cleared Jul 18, 2014
OPTILITE C1 INACTIVATOR KIT
K141100
The Binding Site Group , Ltd.
Immunology · 80d
Cleared Apr 15, 2013
HUMAN C1 INACTIVATOR KIT FOR USE ON SPAPLUS
K122304
The Binding Site Group , Ltd.
Immunology · 257d
Cleared Dec 21, 2007
DIMENSION VISTA C1 IN
K072965
Dade Behring, Inc.
Immunology · 60d
Cleared Jul 25, 2001
K-ASSAY C1-INA
K011780
Kamiya Biomedical Co.
Immunology · 48d
Cleared Mar 19, 2001
C1-INHIBITOR MICROTITER ASSAY DEVICE
K003747
Baxter Healthcare Corp
Immunology · 105d
Cleared Aug 01, 1996
N ANTISERUM TO C1 INHIBITOR
K960257
Behring Diagnostics, Inc.
Immunology · 196d
Cleared May 30, 1995
HUMAN C1 INACTIVATOR OR C-1 ESTERASE INHIBITOR RADIAL IMMUNODIFFUSION KIT
K951967
Kent Laboratories, Inc.
Immunology · 33d
Cleared Jan 17, 1992
COMPLEMENT C1 INACTIVATOR KIT
K915431
The Binding Site, Ltd.
Immunology · 46d
Cleared Jul 16, 1982
ORTHO CLASSICAL PATHWAY COMPL. TEST
K821898
Ortho Diagnostic Systems, Inc.
Immunology · 18d
Cleared Aug 14, 1978
ANTI-HUMAN C1 INHIBITOR SERUM (GOAT)
K781017
Icl Scientific
Immunology · 59d
Cleared Mar 22, 1978
LAS-R HUMAN C1 ESTERASE INHIBITOR TEST
K780335
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 22d

About Product Code DBA - Regulatory Context