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
289–312 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Feb 24, 2014
IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS,...
K133404 · DGC
Phadia AB
Immunology · 110d
Cleared Feb 07, 2014
QUANTA FLASH CENTROMERE
K123880 · LJM
Inova Diagnostics, Inc.
Immunology · 417d
Cleared Jan 28, 2014
GOLD STANDARD DIAGNOSTICS ANTI-NUCLEAR ANTIBODY (ANA) SCREEN ELISA TEST KIT
K131330 · LJM
Gold Standard Diagnostics
Immunology · 265d
Cleared Jan 16, 2014
CALPREST
K130945 · NXO
Eurospital S.P.A.
Immunology · 287d
Cleared Jan 14, 2014
IMMULITE 2000 AFP, BR-MA, AND OM-MA CALIBRATION VERIFICATION MATERIAL
K132739 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 133d
Cleared Jan 07, 2014
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION...
K130122 · CFN
Beckman Coulter, Inc.
Immunology · 355d
Cleared Dec 23, 2013
ELIA(TM) CARDIOLIPIN IGA IMMUNOASSAY
K131821 · MID
Phadia US, Inc.
Immunology · 186d
Cleared Dec 20, 2013
HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT
K132555 · PCN
The Binding Site
Immunology · 128d
Cleared Dec 05, 2013
AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK
K132082 · MST
Aesku Diagnostics
Immunology · 153d
Cleared Oct 30, 2013
IMMULITE 2000
K133122 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 30d
Cleared Oct 25, 2013
IMMULISA ENHANCED CELIAC FUSION (TTG/DGP) IGA/IGG ANTIBODY ELISA
K123713 · MVM
Immco Diagnostics, Inc.
Immunology · 325d
Cleared Oct 21, 2013
BIOPLEX 2200 APLS IGM
K130528 · MID
Bio-Rad Laboratories
Immunology · 234d
Cleared Oct 07, 2013
V8 SP NORMAL CONTROL, ABNORMAL CONTROL
K131479 · JJY
Helena Laboratories
Immunology · 138d
Cleared Sep 25, 2013
MULTICHEM P
K131992 · JJY
Techno-Path Manufacturing , Ltd.
Immunology · 89d
Cleared Sep 20, 2013
IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000...
K132391 · JJX
Siemens Helathcare Diagnostics, Inc.
Immunology · 50d
Cleared Sep 19, 2013
BIOPLEX 2200 CELIAC IGA AND IGG KITS ON THE BIOPLEX 2200 SYSTEM, BIOPLEX 2200...
K130053 · MVM
Bio-Rad Laboratories, Inc.
Immunology · 247d
Cleared Aug 28, 2013
AUTOMATED IN VITRO QUANTITATIVE ASSAY FOR THE MEASUREMENT OF ALLERGEN...
K122197 · DHB
Phadia US, Inc.
Immunology · 400d
Cleared Aug 12, 2013
IMMULITE 2000 PSA CALIBRATION VERIFICATION MATERIAL
K131536 · JJX
Siemens Healthcare Diagnostics, Inc.
Immunology · 75d
Cleared Aug 02, 2013
BD FACS SAMPLE PREP ASSISTANT III
K131301 · PER
Becton, Dickinson & CO
Immunology · 87d
Cleared Jul 26, 2013
CAPILLARYS IMMUNOTYPING, CAPILLARYS 2 INSTRUMENT, IT/IF CONTROL, CAPILLARYS 2...
K130500 · CEF
Sebia
Immunology · 150d
Cleared Jul 15, 2013
TQ-PREP WORKSTATION, PREPPLUS 2 WORKSTATION
K130253 · PER
Beckman Coulter, Inc.
Immunology · 164d
Cleared Jul 15, 2013
ANA SCREEN ELISA (IGG)
K131185 · LJM
Euroimmun US
Immunology · 80d
Cleared Jul 10, 2013
IMMUNOCAP SPECIFIC IGE CONTROL L, IMMUNOCAP SPECIFIC IGE CONTROL M AND...
K131738 · DHB
Phadia AB
Immunology · 27d
Cleared Jul 03, 2013
HUMAN ALPHA-1 ANTITRYPSIN KIT SPAPLUS
K123256 · DEM
The Binding Site Group , Ltd.
Immunology · 258d