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
577–600 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
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
Not Cleared Apr 26, 2006
PHICAL TEST
DEN060001 · NXO
Genova Diagnostics
Immunology · 34d
Cleared Apr 24, 2006
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS...
K060940 · JIX
Ortho-Clinical Diagnostics, Inc.
Immunology · 18d