DAK · Class II · 21 CFR 866.5240

FDA Product Code DAK: Complement C1q, Antigen, Antiserum, Control

Leading manufacturers include Ortho Diagnostic Systems, Inc., The Binding Site, Ltd. and Hyland Therapeutic Div., Travenol Laboratories.

28
Total
28
Cleared
96d
Avg days
1977
Since

FDA 510(k) Cleared Complement C1q, Antigen, Antiserum, Control Devices (Product Code DAK)

28 devices
1–24 of 28
Cleared Sep 10, 2003
BINDAZYME CLQ CIC EIA KIT
K031563
The Binding Site, Ltd.
Immunology · 114d
Cleared May 30, 1995
HUMAN C1Q RADIAL IMMUNODIFFUSION KIT
K951968
Kent Laboratories, Inc.
Immunology · 33d
Cleared Oct 28, 1991
C1 RID KIT
K914388
The Binding Site, Ltd.
Immunology · 27d
Cleared Jan 09, 1987
IC MICROASSAY
K864312
Diamedix Corp.
Immunology · 67d
Cleared Feb 04, 1985
CORDIA IC
K844294
Cordis Corp.
Immunology · 90d
Cleared Jun 13, 1984
ORTHO* SERUM ELISA TEST SYSTEM
K833636
Ortho Diagnostic Systems, Inc.
Immunology · 240d
Cleared Aug 27, 1982
ORTHO* ALTERNATIVE PATHWAY COMPL. TEST
K821949
Ortho Diagnostic Systems, Inc.
Immunology · 58d
Cleared Jun 25, 1982
ORTHO CLG IMMUNE COMPLEX TEST SYSTEM
K821806
Ortho Diagnostic Systems, Inc.
Immunology · 8d
Cleared Dec 27, 1979
ELECTRO-IMMUNO-QUANTITATION (EIQ)
K792472
Icl Scientific
Immunology · 24d
Cleared Aug 14, 1978
ANTI-HUMAN CIQ SERUM
K781022
Icl Scientific
Immunology · 56d
Cleared May 18, 1978
LAS-R HUMAN COMPLEMENT CLQ TEST
K780729
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 16d
Cleared Nov 03, 1977
HUMAN REFERENCE SERUM C4 COMPLEMENT
K772003
G.D. Searle and Co.
Immunology · 13d
Cleared Jun 24, 1977
GOAT ANTISERUM COMPLEMENT C3 NEPHEL.
K770964
Kallestad Laboratories, Inc.
Immunology · 28d
Cleared May 03, 1977
LAS-R TM HUMAN COMPLEMENT C4 TEST
K770547
Hyland Therapeutic Div., Travenol Laboratories
Immunology · 43d

About Product Code DAK - Regulatory Context