Atlas FDA

DEW

76 FDA 510(k) clearances · Product code

41 daysmedian time to decision
129 days90th percentile
76clearances measured

FDA profile

Official device name
Igg, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5510
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
1996: 1 · 2009: 4 · 2011: 16 · 2020: 19
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
TINA-QUANT IGG GEN.2 (K050113)Roche Diagnostics Corp.2005-02-08
ROCHE DIAGNOSTICS TINA-QUANT IGG GEN.2 (K040434)Roche Diagnostics Corp.2004-03-10
SPIFE IFE CALIBRATOR AND CONTROL KIT (K010617)Helena Laboratories2001-03-15
WAKO-IGG II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOLOBULIN STANDARD (K993928)Wako Chemicals USA, Inc.2000-01-18
K-ASSAY IGG (K993281)Kamiya Biomedical Co.1999-11-09
IGG (K983221)Abbott Laboratories1998-11-04
SYNCHRON LX SYSTEMS IMMUNOGLOBULIN G/A/M REAGENT (K965108)Beckman Instruments, Inc.1997-03-06
IMAGE-IMMUNOCHEMISTRY SYSTEM URINE IMMUNOGLOBULIN (K963974)Beckman Instruments, Inc.1997-03-06
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (K963868)Beckman Instruments, Inc.1997-02-10
QUANTEX IGG (K962202)Instrumentation Laboratory CO1996-09-26
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR (K955798)Randox Laboratories, Ltd.1996-04-05
BECKMAN IMMUNOGLOBULIN G (IGG) REAGENT, URINE APPLICATION, URINE PROTEIN CALIBRATOR, CONTROL (K951635)Beckman Instruments, Inc.1995-05-15
BEHRING NEPHELOMETER II (K943997)Behring Diagnostics, Inc.1994-10-03
OT IGG SORBENT (K934324)Organon Teknika Corp.1994-04-21
RADIAS FERRITIN ENZYME IMMUNOASSAY (K933314)Bio-Rad1993-09-08
ZORBA(TM) IGG REMOVAL REAGENT (K924197)Zeus Scientific, Inc.1992-12-15
IGG SUCLASS EIA (K921575)Virotech Diagnostika1992-05-28
ELISA COMBI-KIT HUMAN IGG SUBCLASSES (K911610)Janssen Research Foundation1991-06-12
MODIFIED TECHNICON DPA-1(TM) SYSTEM (K900943)Technicon Instruments Corp.1990-04-26
COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) (K893419)Coulter Immunology1989-08-03
VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (K891385)Vitek Systems, Inc.1989-04-18
SPQ(TM) ANTIBODY REAGENT SET II FOR IGG (K890416)Atlantic Antibodies1989-02-22
ACCRAASSAY RID KITS (K882369)Icn Immunobiologicals1988-07-12
QM300 IGG ANTIBODY PACK (K882083)Kallestad Diag, A Div. of Erbamont, Inc.1988-07-08
WAKO(TM) IGG-HA DIRECT (K880784)Wako Chemicals USA, Inc.1988-06-06
GULLSORB IGG INACTIVATION REAGENT (K875254)Gull Laboratories, Inc.1988-02-17
IMMUNOGLOBULIN G & G SUBCLASSES (K875356)Birmingham1988-02-10
IMMUNOGLOBULINS G (K873870)Unipath , Ltd.1987-10-13
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT (K872800)Abbott Laboratories1987-08-12
QM300 IGG ANTIBODY PACK (K871340)Kallestad Diag, A Div. of Erbamont, Inc.1987-04-22
PENTAVALENT ANTISERUM TO HUMAN IMMUNOGLOBULINS (K871352)Helena Laboratories1987-04-22
TINA-QUANT(R) IGG (K862764)Boehringer Mannheim Corp.1986-09-03
DAKO ITA SYSTEM (K861059)Dako Corp.1986-08-25
GILFORD IMMUNOGLOBULIN G REAGENT (K853465)Gilford1985-09-16
TDX IMMUNOGLOBULIN G DIAGNOSTIC KIT (K852589)Abbott Laboratories1985-07-15
DART IMMUNOGLOBULINS REAGENT SYSTEM (K851541)Coulter Electronics, Inc.1985-07-15
SPQ TEST SYSTEM FOR IMMUNOGLOBULIN G (K850583)Applications Lab1985-03-01
AMER. HISTO-ID SYS PRIMARY IGG S7920-11 (K842329)Bartels Immunodiagnostic Supplies, Inc.1984-08-02
OPTIMATE IGG TEST (K841816)Miles Laboratories, Inc.1984-06-22
TECH. RA-1000SYS-ANALYTES IMMUNOGLOBULIN (K833402)Technicon Instruments Corp.1984-01-24
GOAT ANTI-HUMAN IGG Y CHAIN SPECIFIC (K832258)Gelco Diagnostics, Inc.1983-10-31
FITC GOAT ANTI-HUMAN IGG Y CHAIN (K832264)Gelco Diagnostics, Inc.1983-10-28
TIA-IGG REAGENT & CALIBRATOR SETS (K831101)Worthington Diagnostic Systems1983-04-27
TITAN IMMUNO-FIX (K830594)Helena Laboratories1983-03-24
ANTIHUMAN IGG GLOBULIN FITC LABELED (K821018)Microbiological Research Corp.1982-04-29
DAKO PAP KIT K505 (K812484)Dako Corp.1982-02-10
ACA IMMUNOGLOBULIN G ANALYTICAL TEST (K812664)E.I. Dupont DE Nemours & Co., Inc.1981-10-02
ACA IMMUNOGLOBULIN G CALIBRATOR (K812630)E.I. Dupont DE Nemours & Co., Inc.1981-09-29
SCRIPPSYSTEM IMMUNOGLOBIN RID KIT (K812453)Scripps-Miles, Inc.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGG (K812489)Dako Corp.1981-09-23
IMMUNOGL. FRCT. OF RABBIT ANTISER.-ALPHA (K812495)Dako Corp.1981-09-23
SCRIPPSYSTEM NEPHELOMETRIC ANTISERA KIT (K812328)Scripps-Miles, Inc.1981-09-08
PHADEBAS IGG RAST TEST (K810694)Pharmacia, Inc.1981-07-23
AIM SYSTEM (FOR IGG) (K811126)Icl Scientific1981-05-08
IMMUNOLOGY CONTROL SERUM (K810056)Icl Scientific1981-02-09
GOAT ANTI-HUMAN IGG GAMMA CHAIN SPECIFIC (K802257)Protos Laboratories1980-10-31
J.T. BAKER IMMUNOGLOBULIN G NEPHELOMETRI (K801281)J.T. Baker Chemical Co.1980-06-20
RID SYSTEM-QUAD MULTITEST IGG, IGA,ETC. (K800897)Icl Scientific1980-05-08
GEMENI IGG ASSAY (K800451)Electro-Nucleonics Laboratories, Inc.1980-04-24
PARACONTROL ABNORMAL IMMUNOGLOBULIN CONT (K800398)Diagnostica, Inc.1980-03-12
IMMUNOGLOBULIN G REAGENT SYSTEM (K800119)Calbiochem-Behring Corp.1980-02-05
ANTI-HUMAN IGG SERUM (K791281)Diagnostica, Inc.1979-11-27
ANTI-HUMAN GLOBULINS (K791285)Diagnostica, Inc.1979-10-17
ANTISERUM TO HUMAN IMMUNOGLOBULINS (K791824)Icl Scientific1979-10-17
LANCER L-INA ANTI-IGG (K791403)Sherwood Medical Co.1979-10-17
ANTISERUM, HUMAN, IGG H & L CHAIN (K790702)Kent Laboratories, Inc.1979-09-04
ANTISERUM TO HUMAN IGG (K790704)Kent Laboratories, Inc.1979-04-12
RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.G (K772077)Gelman Instrument Co.1978-02-03
IMMUNOGLOBULIN G NEPHEL. ASSAY (K772252)Kallestad Laboratories, Inc.1977-12-22
GOAT ANTISERUM IGG NEPHELOMETRIC (K770961)Kallestad Laboratories, Inc.1977-06-24
RHODAMINE-CONJUGATED ANTISERUM (K770669)Kent Laboratories, Inc.1977-04-28
FLUORESCEIN CONJUGATED ANTISERUM (K770668)Kent Laboratories, Inc.1977-04-28
DASP TM ANTI-RABBIT (K770597)Organon, Inc.1977-04-28
ULTRA LOW LEVEL IMMUNOGLOBULIN G (K761224)Intl. Diagnostic Technology1977-04-07
FLUOR. CONJUGATED ANTISERUM (K770484)Kent Laboratories, Inc.1977-03-21
SERUM, IGG GOAT ANTI-HUMAN ACID (K760145)Oxford Laboratories, Inc.1976-07-19

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