ClearanceBrief
Panels › Immunology › Product code CFN · Class 2

Method, Nephelometric, Immunoglobulins (G, A, M)

Regulation 866.5510

0510(k)s in 12 months (61 all time)
0recalls in 12 months (20 all time)
18recalls that name a 510(k)
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Top companies in CFN

Company510(k)sRecalls
The Binding Site Group , Ltd.1411
The Binding Site150
Beckman Coulter, Inc.44
Dade Behring, Inc.60
Siemens Healthcare Diagnostics24
Antibodies, Inc.30
Crestat Diagnostics, Inc.30
Olympus America, Inc.30
Behring Diagnostics, Inc.20
Wako Chemicals USA, Inc.20
Decided510(k)Device and applicantCode
Mar 22, 1994K933970N-ASSAY TIA IGM
Crestat Diagnostics, Inc.
CFN
Jan 28, 1994K933973N-ASSAY TIA MULTI V-NL
Crestat Diagnostics, Inc.
CFN
Aug 20, 1992K923070WAKO IGG-HA
Wako Chemicals USA, Inc.
CFN
Apr 7, 1988K880356N PROTEIN STANDARD PLASMA (HUMAN)
Behring Diagnostics, Inc.
CFN
May 15, 1987K871343QM2/QM300 BUFFER AND DILUENT PACK
Kallestad Diag, A Div. of Erbamont, Inc.
CFN
Dec 1, 1986K864342MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
Eiken Chemical Co., Inc.
CFN
Apr 15, 1986K860894BEHRING NEPHELOMETER SYSTEM
Behring Diagnostics, Inc.
CFN
Nov 8, 1978K781656NEPHELRATE ANTISERUMS, IGG
Antibodies, Inc.
CFN
Nov 8, 1978K781655NEPHELRATE ANTISERUMS 1GA
Antibodies, Inc.
CFN
Nov 8, 1978K781654NEPHELRATE ANTIPERUMS LGM
Antibodies, Inc.
CFN
Jul 21, 1977K771226LAS-R TEST PROGRAM
Hyland Therapeutic Div., Travenol Laboratories
CFN

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