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
985–1008 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 27, 2000
ANTI-CARDIOLIPIN, MULTIPLE AUTOANTIBODIES IMMUNOLOGICAL TEST SYSTEM
K003069 · MID
Quest Intl., Inc.
Immunology · 56d
Cleared Nov 27, 2000
VARELISA TG (THYROGLOBULIN) ANTIBODIES,
K003414 · JZO
Pharmacia & Upjohn Co.
Immunology · 25d
Cleared Nov 20, 2000
N LATEX B2-MICROGLOBULIN
K002731 · JZG
Dade Behring, Inc.
Immunology · 80d
Cleared Oct 26, 2000
ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
K002376 · LTJ
Bayer Corp.
Immunology · 83d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT
K002560 · DGC
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN IGD IMMUNOFIXATION GRADE KIT
K002561 · CZJ
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN LAMBDA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002563 · DEH
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 26, 2000
SHEEP ANTI-HUMAN KAPPA FREE LIGHT CHAIN IMMUNOFIXATION GRADE KIT
K002564 · DFH
The Binding Site, Ltd.
Immunology · 70d
Cleared Oct 25, 2000
K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE
K002558 · DCK
Kamiya Biomedical Co.
Immunology · 72d
Cleared Oct 25, 2000
OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT
K002918 · DCN
Olympus America, Inc.
Immunology · 36d
Cleared Oct 25, 2000
FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER
K003094 · LTJ
Qualigen, Inc.
Immunology · 22d
Cleared Oct 23, 2000
ELECSYS CA 15-3 TEST SYSTEM
K001468 · MOI
Roche Diagnostics Corp.
Immunology · 166d
Cleared Oct 20, 2000
NICHOLS ADVANTAGE THYROGLOB
K002888 · MSW
Nichols Institute Diagnostics
Immunology · 35d
Cleared Oct 19, 2000
GLIADIN IGA ANTIBODY EIA DETECTION SYSTEM
K002169 · MST
Scimedx Corp.
Immunology · 93d
Cleared Oct 19, 2000
GLIADIN IGG ANTIBODY EIA DETECTION SYSTEM
K002189 · MST
Scimedx Corp.
Immunology · 92d
Cleared Oct 19, 2000
MDI GLIADIN A TEST
K002358 · MST
Micro Detect, Inc.
Immunology · 78d
Cleared Oct 19, 2000
MDI GLIADIN G TEST
K002359 · MST
Micro Detect, Inc.
Immunology · 78d
Cleared Oct 19, 2000
ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER
K002905 · MSW
Beckman Coulter, Inc.
Immunology · 31d
Cleared Oct 13, 2000
AUTOSTAT II ENA-6 PROFILE ELISA
K003054 · LLL
Cogent Diagnotics , Ltd.
Immunology · 11d
Cleared Oct 13, 2000
AUTOSTAT II ENA-4 PROFILE ELISA
K003057 · LLL
Cogent Diagnotics , Ltd.
Immunology · 11d
Cleared Sep 29, 2000
BAYER IMMUNO 1 HER-2/NEU ASSAY
K992228 · NCW
Bayer Corp.
Immunology · 455d
Cleared Sep 29, 2000
MANUAL HER-2/NEU MICROTITER ELISA (OSDI HER-2/NEU ELISA)
K994112 · NCW
Oncogene Science, Inc.
Immunology · 298d
Cleared Sep 28, 2000
AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA
K002215 · MOB
Cogent Diagnotics , Ltd.
Immunology · 66d
Cleared Sep 26, 2000
BIOCHECK, INC. B-2 MICROGLOBIN ENZYME IMMUNOASAY TEST KIT, MODEL BC-1061
K001022 · JZG
Biocheck, Inc.
Immunology · 180d