Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Immunology ×
3,794 results
913–936 of 3,794
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 IGM TEST KIT
K013077 · MSV
Corgenix, Inc.
Immunology · 14d
Cleared Sep 28, 2001
REAADS ANTI-BETA 2 GLYCOPROTEIN I IGA TEST KIT
K013079 · MSV
Corgenix, Inc.
Immunology · 14d
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