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
1657–1680 of 3,792
Search insights Median review: 63d Cleared: 100% Top manufacturer: Inova Diagnostics, Inc. Lead specialty: Immunology
Cleared Apr 18, 1996
ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAY
K954832 · LJM
Orgentec
Immunology · 181d
Cleared Apr 10, 1996
EIA KIT FOR THE DETECTION OF GBM ANTIBODIES
K953495 · DBL
Scimedx Corp.
Immunology · 259d
Cleared Apr 05, 1996
IGA IMMUNOTURBIDIMETRIC & CALIBRATOR
K955794 · CZP
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 05, 1996
IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
K955797 · DFT
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Apr 05, 1996
IGG IMMUNOTURBIDIMETRIC & CALIBRATOR
K955798 · DEW
Randox Laboratories, Ltd.
Immunology · 105d
Cleared Mar 22, 1996
KERATIN PRIMARY ANTIBODY
K935161 · DEH
Ventana Medical Systems, Inc.
Immunology · 875d
Cleared Mar 22, 1996
ANTI-KERATIN-HMW PRIMARY ANTI-BODY
K941173 · DEH
Ventana Medical Systems, Inc.
Immunology · 739d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (SM)
K954896 · LKP
Hycor Biomedical, Inc.
Immunology · 185d
Cleared Mar 22, 1996
HYTEC AUTOIMMUNE KITS (RNP)
K954897 · LKO
Hycor Biomedical, Inc.
Immunology · 185d
Cleared Mar 22, 1996
RETINOL BINDING RID KIT
K955881 · CZS
The Binding Site, Ltd.
Immunology · 85d
Cleared Mar 20, 1996
HYTEC AUTOMIMMUNE KIT (DS-DNA)
K954893 · LRM
Hycor Biomedical, Inc.
Immunology · 147d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KITS (SCL-70)
K954894 · LLL
Hycor Biomedical, Inc.
Immunology · 183d
Cleared Mar 20, 1996
HYTEC AUTOIMMUNE KIT (JO-1)
K954895 · LLL
Hycor Biomedical, Inc.
Immunology · 147d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN PIN IMMUNO ASSAY
K955133 · LLL
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
ORGENTEC ENASCREEN ELISA ASSAY
K955134 · LLL
Orgentec
Immunology · 132d
Cleared Mar 20, 1996
ENZYME IMMUNOASSAY ANTI-DOUBLE STRANDED DNA (DSDNA) TEST KIT
K960091 · LRM
Helix Diagnostics, Inc.
Immunology · 69d
Cleared Mar 20, 1996
DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM
K960182 · LRM
Mardx Diagnostics, Inc.
Immunology · 64d
Cleared Mar 19, 1996
EIA KIT FOR THE DETECTION OF ANTI-MPO ANTIBODIES
K954062 · MOB
Scimedx Corp.
Immunology · 203d
Cleared Mar 19, 1996
EIA KIT FOR THE DETCTION OF ANTI-PR3 ANTIBODIES
K954105 · MOB
Scimedx Corp.
Immunology · 201d
Cleared Mar 19, 1996
QUANTA LITE PR3
K955021 · MOB
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Mar 19, 1996
QUANTA LITE MPO
K955022 · MOB
Inova Diagnostics, Inc.
Immunology · 138d
Cleared Mar 13, 1996
PSA CONTROLS
K960154 · JJX
Diagnostic Products Corp.
Immunology · 57d
Cleared Mar 12, 1996
HEMAGEN CRP 150 KIT (EIA METHOD)
K960324 · DCK
Hemagen Diagnostics, Inc.
Immunology · 49d
Cleared Mar 06, 1996
THERATEST KIT (MODIFICATION)
K955481 · LJM
Theratest Laboratories, Inc.
Immunology · 112d