CFN · Class II · 21 CFR 866.5510

FDA Product Code CFN: Method, Nephelometric, Immunoglobulins (g, A, M)

Leading manufacturers include The Binding Site Group , Ltd., The Binding Site, Ltd. and Dade Behring, Inc..

61
Total
61
Cleared
146d
Avg days
1977
Since
61 devices
49–61 of 61
Cleared Sep 28, 1998
COBAS INTEGRA REAGENT CASSETTES
K982382
Roche Diagnostic Systems, Inc.
Immunology · 82d
Cleared Mar 22, 1994
N-ASSAY TIA IGM
K933970
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Mar 22, 1994
N-ASSAY TIA IGA
K933971
Crestat Diagnostics, Inc.
Immunology · 221d
Cleared Jan 28, 1994
N-ASSAY TIA MULTI V-NL
K933973
Crestat Diagnostics, Inc.
Immunology · 168d
Cleared Aug 20, 1992
WAKO IGG-HA
K923070
Wako Chemicals USA, Inc.
Immunology · 56d
Cleared Apr 07, 1988
N PROTEIN STANDARD PLASMA (HUMAN)
K880356
Behring Diagnostics, Inc.
Immunology · 72d
Cleared May 15, 1987
QM2/QM300 BUFFER AND DILUENT PACK
K871343
Kallestad Diag, A Div. of Erbamont, Inc.
Immunology · 43d
Cleared Apr 15, 1986
BEHRING NEPHELOMETER SYSTEM
K860894
Behring Diagnostics, Inc.
Immunology · 36d
Cleared Jul 21, 1977
LAS-R TEST PROGRAM
K771226
Hyland Therapeutic Div., Travenol Laboratories
Chemistry · 20d