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
289–312 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Mar 18, 2014
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA...
K140105 · OPX
The Binding Site
Immunology · 62d
Cleared Feb 26, 2014
IFA 40: HEP-20-10
K131791 · DHN
Euroimmun US
Immunology · 253d
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