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
577–600 of 3,794
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 20, 2006
FERRITIN-LATEX, MODELS 1418-2070, 1418-0279
K062746 · DBF
Medicon Hellas S.A
Immunology · 67d
Cleared Oct 18, 2006
QUANTA LITE PBC SCREEN IGG/IGA ELISA
K061842 · NRI
Inova Diagnostics, Inc.
Immunology · 111d
Cleared Oct 05, 2006
EUROIMMUN ENDOMYSIUM IFA: ESOPHAGUS (MONKEY) KIT
K061408 · MVM
Euroimmun Us, LLC
Immunology · 136d
Cleared Oct 05, 2006
ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920...
K062516 · JNL
Beckman Coulter, Inc.
Immunology · 38d
Cleared Oct 04, 2006
DIMENSION VISTA RF FLEX REAGENT CARTRIDGE
K062035 · JIX
Dade Behring, Inc.
Immunology · 77d
Cleared Sep 22, 2006
DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR,...
K061852 · CZW
Dade Behring, Inc.
Immunology · 84d
Cleared Sep 22, 2006
MODIFICATION TO MYALLERGY TEST
K061979 · JKA
Immunetech Corporation
Immunology · 71d
Cleared Sep 08, 2006
EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.
K060700 · MOB
Euroimmun Us, LLC
Immunology · 177d
Cleared Aug 31, 2006
ELECSYS IGE II IMMUNOASSAY
K061970 · JHR
Roche Diagnostics
Immunology · 50d
Cleared Aug 24, 2006
DIMENSION VISTA IGM FLEX REAGENT CARTRIDGE AND PROTEIN 1 CALIBRATOR AND...
K061845 · CFN
Dade Behring, Inc.
Immunology · 56d
Cleared Aug 03, 2006
ELIA CCP, MODEL 14-5515-01
K061165 · NHX
Sweden Diagnostics (Us), Inc.
Immunology · 99d
Cleared Jul 20, 2006
RANDOX LIQUID PROTEIN CALIBRATOR
K061056 · JIX
Randox Laboratories, Ltd.
Immunology · 94d
Cleared Jul 20, 2006
EL-ANCA: ANTI-MPO, ANTI-PR3, ANTI-MPO AND ANTI-PR3
K061376 · MOB
Theratest Laboratories, Inc.
Immunology · 64d
Cleared Jul 18, 2006
ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS
K052407 · JZO
Fisher Diagnostics
Immunology · 320d
Cleared Jul 06, 2006
SPIFE IFE-15 PENTAVALENT, MODEL 3456, SPIFE IFE-9 PENTAVALENT KIT, MODEL...
K061069 · CFF
Helena Laboratories
Immunology · 80d
Cleared Jul 06, 2006
ADVIA IMS CPSA CONTROL
K061137 · JJY
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jul 06, 2006
BAYER ADVIA IMS PSA CALIBRATOR AND ADVIA IMS CPSA CALIBRATORS
K061139 · JIT
Bayer Healthcare, LLC
Immunology · 73d
Cleared Jul 06, 2006
DIMENSION VISTA IGA FLEX REAGENT CARTRIDGE ASSAY
K061338 · CFN
Dade Behring, Inc.
Immunology · 52d
Cleared Jul 06, 2006
ACCESS TPO ANTIBODY, AND ACCESS TPO ANTIBODY CALIBRATORS, MODELS A12985 AND...
K061382 · JZO
Beckman Coulter, Inc.
Immunology · 49d
Cleared Jun 19, 2006
ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805
K060431 · NYO
Mbl International Corporation
Immunology · 118d
Cleared Jun 06, 2006
OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S):...
K060201 · DHR
Olympus America, Inc.
Immunology · 131d
Cleared May 25, 2006
IMMUGLO ANTI-ENDOMYSIAL ANTIBODY IFA
K060157 · MVM
Immco Diagnostics, Inc.
Immunology · 125d
Cleared May 10, 2006
ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROLS AND SYSTEM...
K052308 · JZO
Fisher Diagnostics
Immunology · 259d
Cleared May 02, 2006
FIDIS DSDNA
K060380 · LSW
Biomedical Diagnostics (Bmd) SA
Immunology · 77d