Atlas FDA

CFN

61 FDA 510(k) clearances · Product code

71 daysmedian time to decision
431 days90th percentile
61clearances measured

FDA profile

Official device name
Method, Nephelometric, Immunoglobulins (G, A, M)
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2010: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (K233663)Siemens Healthcare Diagnostics Products GmbH2023-12-13
Immunoglobulin G (IgG) (K221114)Beckman Coulter Laboratory Systems (Suzhou) Co., Ltd.2023-08-02
Human IgA liquid reagent kit for Use on SPAPlus (K192116)The Binding Site Group , Ltd.2019-09-04
Optilite IgA Kit (K191985)The Binding Site Group , Ltd.2019-08-19
Optilite IgM Kit (K191635)The Binding Site Group , Ltd.2019-07-15
Human IgM Kit for use on SPAPlus (K191465)The Binding Site Group , Ltd.2019-06-27
Optilite IgM CSF Kit (K190686)The Binding Site Group , Ltd.2019-05-28
Optilite IgA CSF Kit (K183151)The Binding Site Group , Ltd.2019-01-23
DxC 700 AU Clinical Chemistry Analyzer, AU IgG Reagent (K162208)Beckman Coulter, Inc.2017-01-09
Optilite IgG4 Kit (K150526)The Binding Site Group , Ltd.2015-05-30
The Optilite IgG3 kit (K142735)The Binding Site Group , Ltd.2014-12-21
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN, BECKMAN COULTER (K130122)Beckman Coulter, Inc.2014-01-07
HUMAN IGA CSF KIT FOR USE ON SPAPLUS (K120901)The Binding Site Group , Ltd.2013-05-30
HUMAN IGG CSF KIT (K120749)The Binding Site Group , Ltd.2013-05-17
HUMAN IGM CSF KIT (K120750)The Binding Site Group , Ltd.2013-05-17
HEVYLITE HUMAN IGM KAPPA AND HEVYLITE IGM LAMBDA KIT (K113823)The Binding Site Group , Ltd.2013-03-27
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (K103824)The Binding Site2012-02-27
HUMAN IGA2 KIT FOR USE ON THE SPAPLUS (K100588)The Binding Site Group , Ltd.2010-08-16
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS (K082823)The Binding Site Group , Ltd.2010-03-01
HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MODULAR P) (K090920)The Binding Site, Ltd.2009-12-30
DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID (K090594)Siemens Healthcare Diagnostics2009-04-29
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) AND N/T PROTEIN CONTROL LC (K083445)Siemens Healthcare Diagnostics2009-03-24
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (K082129)The Binding Site, Ltd.2009-02-10
HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (K081827)The Binding Site, Ltd.2008-12-19
DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYST (K081161)Dade Behring, Inc.2008-07-28
DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR (K073561)Dade Behring, Inc.2008-02-26
OLYMPUS IGA REAGENT (K073489)Olympus America, Inc.2008-02-11
OLYMPUS IGG REAGENT (K073490)Olympus America, Inc.2008-02-11
OLYMPUS IGM REAGENT (K073487)Olympus America, Inc.2008-02-11
HUMAN IGG SUBCLASS LIQUID REAGENT KITS FOR USE ON THE SPAPLUS ANALYSER (K072889)The Binding Site, Ltd.2008-02-01
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND CONTROL L, M AND H (K061845)Dade Behring, Inc.2006-08-24
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY (K061338)Dade Behring, Inc.2006-07-06
N ANTISERA TO HUMAN IMMUNOGLOBULINS (IGG, IGA AND IGM) (K042735)Dade Behring, Inc.2005-02-15
BINDING SITE IGG SUBLCASS OLYMPUS KITS (K042152)The Binding Site2004-11-22
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC (K042475)Ortho-Clinical Diagnostics, Inc.2004-11-10
N LATEX IGM (K032014)Dade Behring, Inc.2003-08-07
HUMAN IGG SUBCLASS KIT FOR USE ON THE BECKMAN IMMAGE ANALYSER (K022083)The Binding Site, Ltd.2002-07-16
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB (K012292)The Binding Site, Ltd.2001-08-31
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T (K012296)The Binding Site, Ltd.2001-08-31
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T (K012295)The Binding Site, Ltd.2001-08-20
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA (K012291)The Binding Site, Ltd.2001-08-20
HUMAN IGG SUBCLASS KIT USE WITH THE BECKMAN IMAGE ANALYZER (K000701)The Binding Site, Ltd.2000-04-27
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN A (IGALC) REAGENT, BECKMAN COULTER CEREBR (K993549)Beckman Coulter, Inc.2000-02-01
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB (K993547)Beckman Coulter, Inc.2000-02-01
WAKO IGM II- HA, IMMUNOLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993924)Wako Chemicals USA, Inc.2000-01-14
IGM MININEPH ANTISERUM (K981784)The Binding Site, Ltd.1999-12-21
IGG AND IGG SUBCLASS NEPHELOMETRIC DIAGNOSTIC TEST KITS (K982100)The Binding Site, Ltd.1999-12-20
HUMAN IGA SUBCLASS BNII COMBI KIT (K981912)The Binding Site, Ltd.1998-12-04
COBAS INTEGRA REAGENT CASSETTES (K982382)Roche Diagnostic Systems, Inc.1998-09-28
N-ASSAY TIA IGA (K933971)Crestat Diagnostics, Inc.1994-03-22
N-ASSAY TIA IGM (K933970)Crestat Diagnostics, Inc.1994-03-22
N-ASSAY TIA MULTI V-NL (K933973)Crestat Diagnostics, Inc.1994-01-28
WAKO IGG-HA (K923070)Wako Chemicals USA, Inc.1992-08-20
N PROTEIN STANDARD PLASMA (HUMAN) (K880356)Behring Diagnostics, Inc.1988-04-07
QM2/QM300 BUFFER AND DILUENT PACK (K871343)Kallestad Diag, A Div. of Erbamont, Inc.1987-05-15
MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX (K864342)Eiken Chemical Co., Inc.1986-12-01
BEHRING NEPHELOMETER SYSTEM (K860894)Behring Diagnostics, Inc.1986-04-15
NEPHELRATE ANTISERUMS 1GA (K781655)Antibodies, Inc.1978-11-08
NEPHELRATE ANTIPERUMS LGM (K781654)Antibodies, Inc.1978-11-08
NEPHELRATE ANTISERUMS, IGG (K781656)Antibodies, Inc.1978-11-08
LAS-R TEST PROGRAM (K771226)Hyland Therapeutic Div., Travenol Laboratories1977-07-21

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Every clearance here is in the API, with alerts when new ones post.