Atlas FDA

Immunology

3,537 FDA 510(k) clearances · Medical specialty

Sort:Newest firstOldest first

Download CSV table Client report (share link) ◉ Watch

Both buttons carry the same predicate table: the CSV downloads for your worksheet, the report is a shareable page for clients. Exports: 3 free/month with an account · reports & watching free.

RecordFirmDate
IMMAGE IMMUNOCHEMISTRY SYSTEM PROPERDIN FACTOR B (PFB) REAGENT (K964843)Beckman Instruments, Inc.1997-03-06
AUTOSTATTMII ANTI-DSDNA (K952567)Cogent Diagnotics , Ltd.1997-03-04
GENZYME DIAGNOSTICS CONTRAST MONO (K963425)Genzyme Diagnostics1997-02-25
IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES (K970198)Scimedx Corp.1997-02-20
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
IMMAGE IMMUNOCHEMISTRY SYSTEM KAPPA LIGHT CHAIN (KAP) REAGENT IMMAGE IMMUNOCHEMISTRY SYSTEM LAMDA LIGHT CHAIN (LAM) REAG (K964260)Beckman Instruments, Inc.1997-02-10
STRATUS MYOGLOBIN GLUOROMETRIC ENZYME IMMUNOASSAY (K965213)Dade Intl., Inc.1997-02-10
VENTANNA ANTI-DESMIN PRIMARY ANTIBODY (K941516)Ventana Medical Systems, Inc.1997-02-10
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM) (K963868)Beckman Instruments, Inc.1997-02-10
ANTI-VIMENTIN PRIMARY ANTIBODY (K941397)Ventana Medical Systems, Inc.1997-02-10
OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT (K963139)Olympus America, Inc.1997-02-06
TARGET MYOGLOBIN TEST (K963680)Texas Immunology, Inc.1997-02-06
BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (K961024)Princeton BioMeditech Corp.1997-02-04
FERR FLEX REAGENT CARTRIDGE (K963498)Dade Chemistry Systems, Inc.1997-01-24
CEP X SPECTRUMORANGE\Y SPECTRUMGREEN DNA PROBE KIT (K954214)Vysis1997-01-21
IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ (K963695)Diagnostic Products Corp.1997-01-17
CEP 12 SPECTRUMORANGE DIRECT LABELED CHROMOSOME ENUMERATION DNA PROBE (K962873)Vysis1997-01-13
MICRO21 WITH NDNA (K964165)Triangle Biomedical Sciences, Inc.1997-01-03
VENTANA CEA PRIMARY ANTIBODY (K940242)Ventana Medical Systems, Inc.1996-12-23
PHARMACIA CAP SYSTEM RAST FEIA (K962976)Pharmacia & Upjohn Co.1996-12-23
C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT (K962049)Polymedco, Inc.1996-12-18
N LATEX CRP MONO REAGENT (K964687)Behring Diagnostics, Inc.1996-12-16
THERATEST EL-RFSCR (K962050)Theratest Laboratories, Inc.1996-12-16
N-ASSAY TIA RHEUMATOID FACTOR TEST KIT (K964415)Kamiya Technology Services1996-12-13
N-ASSAY TIA RHEUMATOID FACOTR MULTI-CALIBRATOR SET (K964418)Kamiya Technology Services1996-12-13
HEMAGEN ENA DSDNA KIT (EIA METHOD) (K962276)Hemagen Diagnostics, Inc.1996-12-05
OLYMPUS FERRITIN IMMUNOTURBIDIMETRIC REAGENT (K963170)Olympus America, Inc.1996-12-02
CEP 8 SPECTRUMORANGE DNA PROBE KIT (K953591)Vysis1996-11-29
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROID MICROSOMAL (TPO) (K962451)Hycor Biomedical, Inc.1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR THYROGLOBULIN (TG) (K962341)Hycor Biomedical, Inc.1996-11-25
C-REACTIVE PROTEIN (CRP):A LATEX SLIDE TEST (K962019)Teco Diagnostics1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR HISTONE (K962450)Hycor Biomedical, Inc.1996-11-25
HY-TEC/MANUAL AUTOIMMUNE KIT FOR MITOCHONDRIA (K962452)Hycor Biomedical, Inc.1996-11-25
RHEUMATOID FACTOR (RF) REAGENTI A LATEX SLIDE TEST (K962015)Teco Diagnostics1996-11-25
IMMULITE LATEX-SPECIFIC IGE (K963245)Diagnostic Products Corp.1996-11-18
ORGENTEC ANTI-SM ELISA (K962062)American Laboratory Products Co., Ltd.1996-11-18
ORGENTEC ANTI-RNP/SM ELISA (K962057)American Laboratory Products Co., Ltd.1996-11-18
ORGENTEC ANTI-SCL 70 ELISA (K962055)American Laboratory Products Co., Ltd.1996-11-15
ORGENTEC ANTI-SS-A(RO) ELISA (K962054)American Laboratory Products Co., Ltd.1996-11-15
ORGENTEC ABTI-SS-BB(LA) ELISA (K962052)American Laboratory Products Co., Ltd.1996-11-15
ORGENTEC ANTI-JO-1 ELISA (K962053)American Laboratory Products Co., Ltd.1996-11-15
DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (K963525)Shield Diagnostics, Ltd.1996-11-07
IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT (K963048)Beckman Instruments, Inc.1996-11-04
IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT (K963061)Beckman Instruments, Inc.1996-11-04
OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT (K962582)Olympus America, Inc.1996-10-18
OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT (K962409)Olympus America, Inc.1996-10-18
ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY (K962926)American Laboratory Products Co., Ltd.1996-10-10
SPECIFIC ALLERGEN MODULES AND MIXED ALLERGEN PANELS FOR ALASTAT MICROPLATE AND ALASTAT EIA ALLERGEN-SPECIFIC IGE SYSTEMS (K961889)Diagnostic Products Corp.1996-10-10
IMMAGE IMMUNOCHEMISTRY SYSTEM HAPTOGLOBIN (HPT) REAGENT (K963286)Beckman Instruments, Inc.1996-10-07
IMMAGE IMMUNOCHEMISTRY SYSTEM TRANSFERRIN (TRF) REAGENT (K963427)Beckman Instruments, Inc.1996-10-07
N LATEX B2-MICROGLOBULIN REAGENT (K955596)Behring Diagnostics, Inc.1996-10-03
VARELISA ANA (4) PROFILE (K963291)Elias U.S.A., Inc.1996-09-30
IFA KIT FOR THE DETECTION OF C-ANCA ANTIBODIES (K962360)Scimedx Corp.1996-09-30
QUALITROL ANA CONTROL SERUM SET (K961815)Consolidated Technologies, Inc.1996-09-27
QUANTEX IGG (K962202)Instrumentation Laboratory CO1996-09-26
QUANTEX C4 (K962198)Instrumentation Laboratory CO1996-09-26
QUANTEX IGM (K962201)Instrumentation Laboratory CO1996-09-25
QUANTEX IGA (K962200)Instrumentation Laboratory CO1996-09-25
QUANTEX C3 (K962199)Instrumentation Laboratory CO1996-09-25
QUALITROL RF CONTROLS (K961545)Consolidated Technologies, Inc.1996-09-24
QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 (K961544)Consolidated Technologies, Inc.1996-09-24
QUALITROL MONO CONTROL SERUM SET (K961550)Consolidated Technologies, Inc.1996-09-24
RELISA ENA SINGLE WELL SCREEN ANTIBODY TEST SYSTEM (K963275)Immuno Concepts, Inc.1996-09-13
HEMAGEN RHEUMATOID FACTOR KIT (EIA METHOD) (K962836)Hemagen Diagnostics, Inc.1996-09-12
UNICAP 100 (K962274)Pharmacia, Inc.1996-09-12
VENTANA ANTI-CD5 PRIMARY ANTIBODY (K941782)Ventana Medical Systems, Inc.1996-09-10
ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY (K962469)American Laboratory Products Co., Ltd.1996-09-09
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER (K962499)Bartels, Inc.1996-09-05
MPO ELISA TEST SYSTEM (K961765)Immunoprobe, Inc.1996-08-19
QUALITROL CRP CONTROL SET (K961829)Consolidated Technologies, Inc.1996-08-19
PR-3 ELISA TEST SYSTEM (K961764)Immunoprobe, Inc.1996-08-19
MYOGLOBIN ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K962344)Bayer Corp.1996-08-15
N ANTISERUM TO C1 INHIBITOR (K960257)Behring Diagnostics, Inc.1996-08-01
COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN (K961824)Roche Diagnostic Systems, Inc.1996-07-23
HYDRAGEL IF, 6 IF, 12 IF PENTA KITS/HYDRAGEL IF, DOUBLE IF, 2 IF, & 4 IF KITS (K960669)Morax1996-07-12
N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2 (K962373)Behring Diagnostics, Inc.1996-07-11
NOVA LITE ANCA (K961340)Inova Diagnostics, Inc.1996-07-10
N LATEX CRP MONO REAGENT (K962523)Behring Diagnostics, Inc.1996-07-10
QUANTA LITE ENA 6 ELISA (K961913)Inova Diagnostics, Inc.1996-07-10
DAKO LABELED STREPTAVIDIN-BIOTIN 2 KIT, AND ENVISION (K951965)Dako Corp.1996-07-05
CHEMMATE(TM) CD43 (K950148)Biotek Solutions, Inc.1996-07-02
RHEUMATOID FACTOR LATEX SLIDE TEST KIT (K961169)Randox Laboratories, Ltd.1996-06-26
THYROGLOBULIN ANTIBODY ELISA (K960370)Immco Diagnostics, Inc.1996-06-20
THYROID PEROXIDASE ANTIBODY ELISA (K960369)Immco Diagnostics, Inc.1996-06-20
LIQUICHEK RHEUMATOID FACTOR CONTROL (K960987)Bio-Rad1996-06-04
DIASTAT ANTI-CARDIOLIPIN KIT (K955303)Shield Diagnostics, Ltd.1996-05-30
VENTANNA ANTI-CD3 PRIMARY ANTIBODY (K941505)Ventana Medical Systems, Inc.1996-05-30
RIBOSOMAL P EIA TEST SYSTEM (K950169)Hogan & Hartson1996-05-23
ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY (K955449)American Laboratory Products Co., Ltd.1996-05-23
ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAY (K954831)Orgentec1996-05-08
ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAY (K954830)Orgentec1996-05-08
RF IGM ELISA TEST SYSTEM (K961277)Zeus Scientific, Inc.1996-05-08
RIT LIVER, KIDNEY, STOMACH IFA KIT (K955431)The Binding Site, Ltd.1996-04-23
RELISA SM/RNP ANTIBODY TEST SYSTEM (K955604)Immuno Concepts, Inc.1996-04-19
RELSIA SCL-70 ANTIBODY TEST SYSTEM (K955602)Immuno Concepts, Inc.1996-04-19
RELSIA SS-A/RO & SS/B LA ANTIBODY TEST SYSTEM (K955603)Immuno Concepts, Inc.1996-04-19
CRP-LATEX SEIKEN XR REAGENT SYSTEM (K960702)Globe Management Support, Inc.1996-04-19
RELISA JO-1 ANTIBODY TEST SYSTEM (K955605)Immuno Concepts, Inc.1996-04-19
RF-LATEX SEIKEN REAGENT SYSTEM (K960703)Globe Management Support, Inc.1996-04-19
← Previous Next →

Track Immunology automatically

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