Atlas FDA

DEH

53 FDA 510(k) clearances · Product code

203 daysmedian time to decision
1050 days90th percentile
53clearances measured

FDA profile

Official device name
Lambda, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5550
Medical specialty
Immunology
Flags
Third-party review eligible
Adverse events (MAUDE)
2021: 12 · 2024: 26
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
VENTANA CD30 (Ber-H2) RxDx Assay (K172471)Ventana Medical Systems, Inc.2018-05-08
FREELITE HUMAN LAMBDA FREE KIT (K140396)The Binding Site Group , Ltd.2014-04-16
LAMBDA LIGHT CHAINS (K083601)SENTINEL CH. SpA2009-06-22
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZER (K033811)The Binding Site, Ltd.2004-01-30
FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER II (K031016)The Binding Site, Ltd.2003-07-15
FREELITE HUMAN LAMBDA FREE KIT (K023131)The Binding Site, Ltd.2003-01-21
FREELITE LAMBDA FREE KIT (K010440)The Binding Site, Ltd.2001-04-26
FREELITE KAPPA FREE KIT (K010441)The Binding Site, Ltd.2001-04-26
LAMBDA IMMAGE FREELITE KIT (K003671)The Binding Site, Ltd.2001-02-01
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT (K002563)The Binding Site, Ltd.2000-10-26
DAKO MOUSE ANTI HUMAN CYTOKERATIN, HIGH MOLECULAR WEIGHT, CLONE 34BE12, MONOCLONAL ANTIBODY FOR IMMUNOENZYMATIC STAINING (K971905)Dako Corp.1997-12-12
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR IMMUNOENZYMATIC STAINING (PRODUCT CODE NO. MO751) (K965022)Dako Corp.1997-11-06
VENTANA CD45 PRIMARY ANTIBODY (K940583)Ventana Medical Systems, Inc.1997-10-20
CHEMMATE LCA (K973393)Ventana Medical Systems, Inc.1997-09-25
VENTANA ANTI-S100 PRIMARY ANTIBODY (K941514)Ventana Medical Systems, Inc.1997-04-25
VENTANA ANTI-MELANOMA PRIMARY ANTIBODY (K941170)Ventana Medical Systems, Inc.1997-04-22
ANTI-MUSCLE ACTIN PRIMARY ANTIBODY (K941707)Ventana Medical Systems, Inc.1997-04-21
VENTANA ANTI-CD8 PRIMARY ANTIBODY (K941784)Ventana Medical Systems, Inc.1997-02-14
VENTANA ANTI-CD4 PRIMARY ANTIBODY (K941604)Ventana Medical Systems, Inc.1997-02-14
VENTANNA ANTI-DESMIN PRIMARY ANTIBODY (K941516)Ventana Medical Systems, Inc.1997-02-10
ANTI-VIMENTIN PRIMARY ANTIBODY (K941397)Ventana Medical Systems, Inc.1997-02-10
VENTANA ANTI-CD5 PRIMARY ANTIBODY (K941782)Ventana Medical Systems, Inc.1996-09-10
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION (K951965)Dako Corp.1996-07-05
CHEMMATE(TM) CD43 (K950148)Biotek Solutions, Inc.1996-07-02
VENTANNA ANTI-CD3 PRIMARY ANTIBODY (K941505)Ventana Medical Systems, Inc.1996-05-30
ANTI-KERATIN-HMW PRIMARY ANTI-BODY (K941173)Ventana Medical Systems, Inc.1996-03-22
KERATIN PRIMARY ANTIBODY (K935161)Ventana Medical Systems, Inc.1996-03-22
CHEMMATE SPECIAL STAIN LCA-CD45 (K936111)Biotek Solutions, Inc.1996-02-27
KERATIN PRIMARY ANTIBODY (K940331)Ventana Medical Systems, Inc.1996-02-26
CHEMMATE(TM) LAMBDA (K950149)Biotek Solutions, Inc.1995-12-06
VENTANA BLUE DETECTION KIT (K940424)Ventana Medical Systems, Inc.1995-11-06
CHEMMATE(TM) L26 (CD20) (K950151)Biotek Solutions, Inc.1995-10-04
DAKO RABBIT ANTI-COW S-100 POLYCLONAL ANTIBODY (K931192)Dako Corp.1995-04-20
DAKO MOUSE ANTI-HUMAN T-CELL (K924804)Dako Corp.1994-11-21
DAKO MOUSE ANTI-HUMAN B-CELL (DAKO-C020-L26 MONO ANTI (K924726)Dako Corp.1994-06-13
DAKO MOUSE ANTI-HUMAN MELANOMA (DAKO ANTI-HMB45) (K932136)Dako Corp.1994-06-13
PSA ANTIBODY KIT (K932326)Ventana Medical Systems, Inc.1993-08-06
MOUSE ANTI-HUMAN LEUCOCYTE ANTIGEN & DAKO PAP KIT (K896918)Dako Corp.1990-08-27
BECKMAN LAMBDA LIGHT CHAIN REAGENT (ADD'L CLAIMS) (K902485)Beckman Instruments, Inc.1990-06-21
QM300 LAMBDA LIGHT CHAINS ANTIBODY PACK (K875165)Kallestad Diag, A Div. of Erbamont, Inc.1988-01-22
QUANTIMETRIC PLUS LAMBDA REAGENT KIT (K855007)Kallestad Laboratories, Inc.1986-02-26
QUANTIMETRIC PLUS SUPPORT PACK (K855013)Kallestad Laboratories, Inc.1986-02-26
QVANTIMETRIC 2KAPPA AND LAMBDA TEST KIT (K852999)Kallestad Laboratories, Inc.1985-10-21
AMER. HISTO-ID SYS PRIMARY LAMBDA CHAIN (K842328)Bartels Immunodiagnostic Supplies, Inc.1984-08-03
QUANTIMETRIC TM 2 KAPPA & LAMBDA KIT (K841864)Kallestad Laboratories, Inc.1984-07-11
GOAT ANTI-HUMAN LAMBA (K832270)Gelco Diagnostics, Inc.1983-10-31
GOAT ANTI-HUMAN LAMBA AFFINITY (K832261)Gelco Diagnostics, Inc.1983-10-28
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA (K812662)Dako Corp.1981-09-29
ANTI-HUMAN LAMBDA SERUM (K791283)Diagnostica, Inc.1979-11-27
GOAR ANTI-HUMAN LAMBODA CHAIN (K791115)Protos Laboratories1979-08-03
LAMBDA SERUM (FREE) ANTI-HUMAN (K781025)Icl Scientific1978-07-27
ANTI-HUMAN LAMBDA SERUM (K781220)Icl Scientific1978-07-27
GOAT LAMBDA-LIGHT CHAIN ANTI-HUMAN SERUM (K771768)G.D. Searle and Co.1977-10-07

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