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
1921–1944 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Dec 15, 1993
AUTOANTIBODY PROFILE-6 ELISA TEST SYSTEM
K933267 · LJM
Zeus Scientific, Inc.
Immunology · 162d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGM ANTIBODIES
K933392 · MID
Elias U.S.A., Inc.
Immunology · 149d
Cleared Dec 08, 1993
ELIAS CARDIOLIPIN IGG ANTIBODIES
K933393 · MID
Elias U.S.A., Inc.
Immunology · 149d
Cleared Dec 03, 1993
SYNELISA ANA PROFILE
K932206 · LJM
Elias U.S.A., Inc.
Immunology · 211d
Cleared Dec 03, 1993
LACTOFERRIN MICROASSAY SYSTEM
K934473 · DEG
Touch Scientific, Inc.
Immunology · 80d
Cleared Nov 15, 1993
DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT
K932876 · LKJ
Shield Diagnostics, Ltd.
Immunology · 154d
Cleared Nov 03, 1993
BOEHRINGER MANNHEIM TINA-QUANT TRANSFERRIN ASSAY
K933589 · DDG
Boehringer Mannheim Corp.
Immunology · 100d
Cleared Oct 15, 1993
DIASTAT ANTI-CENTROMERE KIT
K932877 · LLL
Shield Diagnostics, Ltd.
Immunology · 123d
Cleared Oct 12, 1993
ACCESS FOLATE ASSAY
K932887 · CGN
Beckman Coulter, Inc.
Immunology · 120d
Cleared Oct 07, 1993
BECKMAN TRANSFERRIN KIT
K926272 · DDG
Beckman Instruments, Inc.
Immunology · 293d
Cleared Sep 24, 1993
SYNELISA CENP-B ANTIBODIES
K931255 · LKJ
Elias U.S.A., Inc.
Immunology · 196d
Cleared Sep 24, 1993
IMMULITE BETA-2-MICROGLOBULIN
K931702 · JZG
Diagnostic Products Corp.
Immunology · 171d
Cleared Sep 24, 1993
ENZYME IMMONOASSAY EXTRACTABLE NUCLEAR ANTIGEN
K932850 · LLL
Helix Diagnostics, Inc.
Immunology · 106d
Cleared Sep 24, 1993
ADDED USE CLAIM FOR DUPONT ACA BETA-2-MICROGLOBULIN TEST PACK
K933648 · JZG
Dupont Medical Products
Immunology · 59d
Cleared Sep 08, 1993
ENCORE ENA COMBINED EIA
K931543 · LLL
Clark Laboratories, Inc.
Immunology · 163d
Cleared Sep 08, 1993
EYE SPOT IM TEST
K932688 · KTN
J.S. Medical Assoc.
Immunology · 97d
Cleared Sep 08, 1993
RADIAS FERRITIN ENZYME IMMUNOASSAY
K933314 · DEW
Bio-Rad
Immunology · 63d
Cleared Sep 01, 1993
BECKMAN VIGIL PLUS CONTROL
K930850 · JJY
Beckman Instruments, Inc.
Immunology · 195d
Cleared Aug 23, 1993
EYE SPOT CRP TEST
K932180 · DCN
J.S. Medical Assoc.
Immunology · 110d
Cleared Aug 23, 1993
SYLNELISA HISTONE ANTIBODIES
K932302 · LKJ
Elias U.S.A., Inc.
Immunology · 103d
Cleared Aug 23, 1993
EYE SPOT RF TEST
K932437 · DHR
J & S Medical Assoc., Inc.
Immunology · 96d
Cleared Aug 23, 1993
RHEUMELISA II HISTONE ANTIBODY TEST KIT
K932679 · LKJ
Biowhittaker Molecular Applications,...
Immunology · 82d
Cleared Aug 23, 1993
SYNELISA TG ANTIBODIES/TPO ANTIBODIES
K933123 · JZS
Elias U.S.A., Inc.
Immunology · 56d
Cleared Aug 16, 1993
IMMULITE TOTAL IGE
K931703 · JHR
Diagnostic Products Corp.
Immunology · 132d