FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Immunology ×
3,792 results
913–936 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGG TEST KIT
K013080 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 27, 2001
COLOR-MONOGEN
K012901 · KTN
Instrumentation Laboratory CO
Immunology · 29d
Cleared Sep 20, 2001
REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTITIVE TEST KIT
K013018 · MID
Corgenix, Inc.
Immunology · 13d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012371 · DDG
Roche Diagnostics Corp.
Immunology · 55d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012393 · DDG
Roche Diagnostics Corp.
Immunology · 54d
Cleared Sep 07, 2001
ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY...
K012208 · DDC
Beckman Coulter, Inc.
Immunology · 53d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TB
K012292 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 31, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.T
K012296 · CFN
The Binding Site, Ltd.
Immunology · 42d
Cleared Aug 23, 2001
MODIFICATION TO: REAADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE...
K012567 · MID
Corgenix, Inc.
Immunology · 14d
Cleared Aug 20, 2001
DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM
K012053 · MID
Diamedix Corp.
Immunology · 49d
Cleared Aug 20, 2001
POLYTITER SYSTEM
K012163 · DHN
Polymedco, Inc.
Immunology · 40d
Cleared Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE LK001.TA
K012291 · CFN
The Binding Site, Ltd.
Immunology · 31d
Cleared Aug 20, 2001
HUMAN IGG SUBCLASS LIQUID REAGENT KITS, PRODUCT CODE NK001.T
K012295 · CFN
The Binding Site, Ltd.
Immunology · 31d
Cleared Aug 16, 2001
AIA-PACK BRCA, ST AIA PACK BRCA
K010796 · MOI
Tosoh Medics, Inc.
Immunology · 153d
Cleared Aug 03, 2001
VYSIS UROVYSION BLADDER CANCER RECURRENCE KIT
K011031 · MMW
Vysis
Immunology · 120d
Cleared Aug 01, 2001
WAKO IMMUNOASSAY CALIBRATOR SET
K010332 · JIT
Wako Chemicals USA, Inc.
Immunology · 180d
Cleared Jul 30, 2001
MININEPH A-1 TRANSFERRIN ANTISERUM, HIGH AND LOW SERUM CONTROL
K011662 · DDG
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 30, 2001
MININEPH A-1 ANTITRYPSIN ANTISERUM, HIGH AND LOW SERUM CONTROLS
K011663 · DEM
The Binding Site, Ltd.
Immunology · 62d
Cleared Jul 27, 2001
QUANTA PLEX ENA PROFILE 4
K011140 · LLL
Inova Diagnostics, Inc.
Immunology · 105d
Cleared Jul 25, 2001
K-ASSAY C1-INA
K011780 · DBA
Kamiya Biomedical Co.
Immunology · 48d
Cleared Jul 17, 2001
ABBOTT TUMORMARKER-MCC (LYOPHILIZED), LEVELS 1 AND 2, 2ML NO. 6E21-10
K011853 · JJY
Bio-Rad
Immunology · 34d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGA ELISA
K011566 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jul 09, 2001
QUANTA LITE H-TTG (HUMAN TISSUE TRANSGLUTAMINASE) IGG ELISA
K011570 · MVM
Inova Diagnostics, Inc.
Immunology · 49d
Cleared Jun 26, 2001
LYPHOCHEK TUMOR MARKER CONTROL, LEVELS 1 AND 2, 2ML, MODEL 580
K011579 · JJY
Bio-Rad
Immunology · 35d