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
3241–3264 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Nov 24, 1981
ACA ANTITHROMBIN III PLASMINOGEN CALIB
K812626 · JBQ
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 70d
Cleared Nov 02, 1981
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
K812556 · JJY
American Dade
Immunology · 55d
Cleared Oct 26, 1981
H-103 IGG, H-104 IGA, H-105 IGM
K812821 · DFZ
Immulok, Inc.
Immunology · 19d
Cleared Oct 26, 1981
IMMUNEX CRP
K812881 · DCN
Armkel, LLC
Immunology · 12d
Cleared Oct 23, 1981
NUCLEAR ANTIGENS
K810592 · LLL
Alpha Antigens, Inc.
Immunology · 232d
Cleared Oct 23, 1981
ELUTION SOLUTION
K812565 · KSG
Biological Corp. of America
Immunology · 44d
Cleared Oct 23, 1981
DISPENSER ASPIRATOR DA 300
K812782 · JQW
Pharmacia, Inc.
Immunology · 18d
Cleared Oct 23, 1981
FERRITIN(125I) RADIOIMMUNOASSAY TEST SYS
K812786 · DBF
Corning Medical & Scientific
Immunology · 18d
Cleared Oct 19, 1981
FERRITIN KIT
K812597 · DBF
Hybritech, Inc.
Immunology · 35d
Cleared Oct 02, 1981
ACA IMMUNOGLOBULIN G ANALYTICAL TEST
K812664 · DEW
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 11d
Cleared Sep 29, 1981
ACA PLASMINOGEN TEST PACK
K812625 · DDX
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN G CALIBRATOR
K812630 · DEW
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN A TEST PACK
K812631 · CZP
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBIN M TEST PACK
K812632 · DFT
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
ACA IMMUNOGLOBULIN A/M CALIBRATORS
K812633 · CZP
E.I. Dupont DE Nemours & Co., Inc.
Immunology · 14d
Cleared Sep 29, 1981
CEA CONTROL PLASMA
K812658 · DHX
Pacific Hemostasis
Immunology · 11d
Cleared Sep 29, 1981
IMMUNOGL. FRACT. OF RABBIT ANTIS./KAPPA
K812661 · DFH
Dako Corp.
Immunology · 11d
Cleared Sep 29, 1981
IMMUNOGL. FRACT. OF RABBIT ANTIS./LAMBDA
K812662 · DEH
Dako Corp.
Immunology · 11d
Cleared Sep 24, 1981
CORDIA IM
K812540 · KTN
Cordis Corp.
Immunology · 20d
Cleared Sep 23, 1981
EM-X
K812222 · KSG
Biological Corp. of America
Immunology · 47d
Cleared Sep 23, 1981
SCRIPPSYSTEM IMMUNOGLOBIN RID KIT
K812453 · DEW
Scripps-Miles, Inc.
Immunology · 26d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL
K812486 · DDB
Dako Corp.
Immunology · 23d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGM
K812487 · DAO
Dako Corp.
Immunology · 23d
Cleared Sep 23, 1981
IMMUNOGL. FRCT. OF RABBIT ANTISER.-IGA
K812488 · CZP
Dako Corp.
Immunology · 23d