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
985–1008 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Cleared Sep 26, 2000
BN PROSPEC SYSTEM
K001647 · JZW
Dade Behring, Inc.
Immunology · 119d
Cleared Sep 12, 2000
EL-ANA PROFILES-2K1
K002559 · LJM
Theratest Laboratories, Inc.
Immunology · 26d